Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.04.2019 – 30.06.2019

Швейцарія

https://fsca.swissmedic.ch/mep/#/

7.06.2019 (Updated02.07.2019)	Intuitive Surgical, Inc	da Vinci Xi EndoWrist SureForm 60 Reload Model: 48360T-08, 48360G-08 Lot: See FSN	MD: Surgical staple loading unit, non-cutting	DE-1 EN-1	Vk_20190614_12
21.06.2019 (Updated02.07.2019)	Dexcom, lnc.	G4 Platinum System Model: All receivers - applies to product generation Dexcom G5 Mobile Model: All receivers - applies to product generation	MD: Percutaneous glucose monitoring system MD: Percutaneous glucose monitoring system	DE-1 FR-1 IT-1 EN-1	Vk_20190522_15
01.07.2019	GE Healthcare Finland Oy	ECG trunk cables ECG Leadwire	MD: Electrical-only medical device connection cable, reusable MD: Electrocardiographic lead set, reusable	DE-1 FR-1 IT-1 EN-1	Vk_20190627_10
25.06.2019 (Updated01.07.2019)	KeyMed Medical & Industrial Equipment	Nurses Control Panel Arm - Long Model: MAJ-1664, K10021798 Lot: All lot numbers prior to 606852	MD: Medical device integration rack	DE-1 FR-1 IT-1 EN-1	Vk_20190621_22
01.07.2019	Bracco Injeneering S.A.	Day Set III HP Model: 640060 Lot: 2018091403, 2018092003, 2018092004, 2019031101, 2019031601, 2019041904	MD: Contrast medium injection system syringe	DE-1 FR-1 IT-1 EN-1	Vk_20190619_17
27.06.2019 (Updated28.06.2019)	REPROLIFE	Warming Solution Set 205 (Solutions) Lot: See Annex Warming Kit 102 (Solutions + Plate) Lot: See Annex Vitrification Solution Set 110 (Solutions) Lot: See Annex Vitrification Kit 101 (Solutions + Plate + Cryotec) Lot: See Annex Value Pack LL (VK101x47, WK102x47) Lot: See Annex Value Pack SS (VK101x4, WK102x4) Lot: See Annex	MD: IVF medium kit MD: IVF medium kit MD: IVF medium kit MD: IVF medium kit MD: IVF medium kit MD: IVF medium kit	EN-2	Vk_20190523_18
03.06.2019 (Updated28.06.2019)	EKF-diagnostic GmbH	Quo-Lab A1c Test Kit Model: 0055 Lot: See FSN	IVD: Glycated haemoglobin (HbA1c) IVD, reagent	DE-1 FR-1 EN-1	Vk_20190522_18
28.06.2019 (Updated28.06.2019)	Dietz Reha-Produkte	Ligero Model: 322NPU/323NPU S/N: 346V XXXXXX with production date 2014-2018	MD: Leichtgewicht-Rollator	DE-1 FR-1 IT-1 EN-1	Vk_20190507_10
03.04.2019 (Updated28.06.2019)	Roche Diagnostics GmbH	BILD2 (Bilirubin direct Gen.2) Model: 05168384190 Lot: 33798101, 35714101 cobas c 701 / 702	IVD: Conjugated (direct) bilirubin IVD, kit, spectrophotometry IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated	FR-1 EN-1 EN-2	Vk_20190329_14
13.03.2019 (Updated28.06.2019)	BioFire Diagnostics, LLC	FilmArray Gastrointestinal (GI) Panel Model: RFIT-ASY-0104 / RFIT-ASY-0116 Lot: All lots with expiration date of 23 October 2019 onward	IVD: Multiple Parameters - Infect. Immunology	DE-2 FR-2 EN-1 EN-2 EN-3	Vk_20190306_16
25.06.2019 (Updated27.06.2019)	Stöpler Instrumenten & Apparaten B.V.	COCUNE - Feuchte Waschhandschuhe (parfümiert/unparfümiert) Model: CCN 21-1001, CCN 21-1002, CCN 21-1004, CCN 21-1005 Lot: 03102, 03192, 03188,	MD: wash gloves	DE-1 FR-1 IT-1 EN-2	Vk_20190624_17
27.06.2019	Datascope Corp.	CARDIOSAVE Hybrid Intra-Aortic Balloon Pump Model: 0998-00-0800-XX, 0998-UC-0800-XX, 0998-00-3013-XX, 0998-00-3023-XX;N/A Lot: N/A S/N: All Cardiosave serial numbers distributed March 6, 2012 to present All CS100 and CS300 serial numbers distributed March 24, 2003 to present SW-Version: N/A	MD: Intra-aortic balloon pump	EN-1	Vk_20190619_15
26.06.2019	Horiba ABX SAS	Yumizen H1500 Yumizen H2500	IVD: Haematology analyser, cell differential IVD: Haematology analyser, cell differential	EN-1	Vk_20190621_15
26.06.2019	Roche Diagnostics GmbH	MYO2 (Tina-quant Myoglobin Gen.2) Model: 04580010190 Lot: see FSN	IVD: Myoglobin IVD, kit, chemiluminescent immunoassay	EN-1	Vk_20190621_05
26.06.2019	Siemens Healthcare GmbH	Artis Zee Artis Q	MD: Stationary angiographic x-ray system, digital MD: Stationary angiographic x-ray system, digital	DE-1 FR-1	Vk_20190621_04
26.06.2019	Immundiagnostik AG	IDKmonitor lnfliximab total ADA, IDKmonitor Adalimumab total ADA, Remsima Monitor total ADA, 25(OH)-Vitamin D direct day ELISA, 25(OH)-Vitamin D dried blood ELISA, PreventlD Cardiac Troponin I, PreventlD Vital-D Model: see FSN Lot: all	IVD: IMMUNOCHEMISTRY (IMMUNOLOGY)	EN-1	Vk_20190621_01
25.06.2019	Biomet Orthopedics	Comprehensive Reverse Shoulder Instrument Case Model: 595509, 595510 Lot: All Lots	MD: Instrument tray	DE-1 FR-1 IT-1 EN-1	Vk_20190624_18
25.06.2019	Abbott	Ellipse VR/DR Model: CD2377-36QC, CD2377-36C, CD1377-36QC, CD1377-36C S/N: See attached List of affected serial numbers	AIMD: Implant, cardiac pacemaker	EN-1	Vk_20190621_16
24.06.2019	MEDOS Medizintechnik AG	Deltastream DP3 Pumphead in support.set Säuglinge, hilite 800 LT, rheoparin beschichtet, Modell Medos (Schlauchset MEH2C4024) Model: 190104M354 Lot: 190104M354	MD: Cardiopulmonary bypass system centrifugal pump	EN-1	Vk_20190617_14
24.06.2019	Siemens Healthcare Diagnostics Inc	Stratus CS Acute Care cTnI TestPak	IVD: Troponin kit	FR-1 EN-1	Vk_20190612_14
18.06.2019 (Updated21.06.2019)	Natus Medical Denmark, GN Otometrics A/S	Chartr EP 200 Model: See FSN S/N: All	MD: Auditory stimulator	DE-1 FR-1 IT-1 EN-1	Vk_20190617_05
21.06.2019 (Updated21.06.2019)	Intrinsic Therapeutics Inc.	Barricaid Model: 2730815-EU, 2731015-EU, 2731215-EU, Catalogue: BAR-D8-8X14, BAR-D8-10X14, BAR-D8-12X14 Lot: all	MD: Lumbar total disc replacement prosthesis	DE-1 FR-1 EN-1	Vk_20190614_04
21.06.2019	Dedienne Santé	orientation guide SYMBOL CUP Instrum SYMBOL STEM Instrument ADES Instrument SHIVA Instrument TRICCC Instrument SMS Instruments	MD: Orthopaedic prosthesis implantation instrument, reusable MD: Acetabular orthopaedic reamer MD: Acetabulum prosthesis trial, reusable MD: Femoral head prosthesis trial MD: Femoral stem prosthesis trial MD: Orthopaedic prosthesis implantation instrument, reusable	DE-1 FR-1 IT-1 EN-1	Vk_20190614_02
21.06.2019	ES-Medical AB	C-10 Probetester Model: T80002 S/N: 0710003 - 1705001, 17080001 - 1801014	MD: Test and disinfection equipment for probes	DE-1 DE-1	Vk_20190529_14
04.06.2019 (Updated21.06.2019)	Covidien LLC	Endo GIA, Surgical Stapling Single Use Loading Units, Tri-Staple 2.0 Model: EGIA30AMT, EGIA45CTAMT, EGIA60AXT, EGIA60CTAMT, SIG30AMT, SIG45AXT, SIG45CTAMT, SIG60AXT, SIG60CTAMT, EGIA45AMT, EGIA60AMT Lot: see FSN	MD: Surgical staple, non-biodegradable	DE-2 FR-2 IT-2 EN-1	Vk_20190529_09
19.06.2019 (Updated20.06.2019)	Ortho-Clinical Diagnostics, Inc	ORTHO AutoVue Innova / Ultra, ORTHO VISION / VISION Max Model: VISION: 6904579, VISION Max: 6904578, AutoVue Innova: 707010, AutoVue Ultra: 6902058	IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated	EN-1 EN-2	Vk_20190613_02
20.06.2019	Abbott GmbH & Co. KG	Alinity ci-series System Control Module Model: 03R70-01 S/N: all	IVD: Chemiluminescent immunoassay analyser IVD, automated	DE-1 FR-1 IT-1 EN-1	Vk_20190612_07
19.06.2019	Siemens Healthcare GmbH; Business Area Advanced Therapies	Artis Zee AXIOM Artis systems	MD: Stationary angiographic x-ray system, digital MD: Stationary angiographic x-ray system, digital	DE-1 FR-1 IT-1	Vk_20190617_11
19.06.2019	Critical Diagnostics	Presage ST2 Assay Model: BC-1065E Lot: All S/N: n/a SW-Version: n/a	IVD: Other Cardiac Markers	EN-1	Vk_20190614_14
18.06.2019	EMED SP. Z O.O. SP. K.	RF electrosurgical unit for arthroscopy Model: 11010042	MD: Electrosurgical Units	DE-1 FR-1 EN-1	Vk_20190617_17
18.06.2019	DIAsource	VIP RIA (Vasoactive intestinal polypeptide) Model: RB311, RB311RUO Lot: 191601	IVD: Vasointestinal Peptide	EN-1	Vk_20190613_15
18.06.2019	Magnisense	MiAG\|cTnI Model: 10030201	IVD: Troponin I/T	EN-1	Vk_20190611_02
28.05.2019 (Updated18.06.2019)	Medtronic MiniMed	Guardian Connect Application Model: CSS7200 SW-Version: Versions prior v3.2.4	MD: Patient health record information system application software	DE-1 FR-1 IT-1 EN-1	Vk_20190527_26
29.01.2019 (Updated17.06.2019)	MAQUET Cardiovascular LLC	AXIUS Blower Mister Model: CB-1000 Lot: 96255605, 96255607, 96255608, 96255609, 96255611; Expanded lot numbers: 96255614, 96255615, 96255616, 96255617, 96255618, 96255619, 96255620, 96255621, 96255622, 96255623	MD: Surgical irrigation tubing set, single-use	EN-1 EN-2	Vk_20190128_05
12.06.2019 (Updated14.06.2019)	Roche Diabetes Care GmbH	Accu-Chek Insight S/N: All	MD: Ambulatory insulin infusion pump, electronic	DE-1.1 DE-1.2 FR-1.1 FR-1.2 IT-1.1 IT-1.2 EN-1.1 EN-1.2	Vk_20190606_13
13.06.2019	DiaMed GmbH	DiaClon Rh-Subgroups + K Model: 50110 // 50115; 001397 / 001398 // 002124 / 002127 / 002126 / 002125 Lot: All lot numbers until further notice S/N: NA SW-Version: NA	IVD: Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination	EN-1	Vk_20190605_15
13.06.2019	Abbott Laboratories	ARCHITECT Complement C3; ARCHITECT Immunoglobulin A; ARCHITECT Immunoglobulin G; ARCHITECT Immunoglobulin M; ARCHITECT Apolipoprotein A1; ARCHITECT Complement C4; ARCHITECT Haptoglobin; ARCHITECT Apolipoprotein B; ARCHITECT Transferrin	IVD: IMMUNOCHEMISTRY (IMMUNOLOGY)	EN-1	Vk_20190605_10
07.06.2019 (Updated13.06.2019)	Datascope Cardiac Assist Division	SENSATION PLUS 7.5Fr. 40cc IAB Model: 0684-00-5658-01 Lot: 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, 3000091828	MD: Intra-aortic balloon pump	DE-1 FR-1 EN-1	Vk_20190603_04
12.06.2019	Roche Diagnostics GmbH	cobas 8800 System Model: 05412722001 S/N: n.a. SW-Version: n.a. cobas 6800 System Model: 05524245001 S/N: n.a. SW-Version: n.a.	IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated	EN-1, Diagnostic EN-1, Screening	Vk_20190611_05
12.06.2019	Randox Laboratories Ltd	Assayed Bovine Multi-Sera - Level 1 Model: AL1027 Lot: 205SL	IVD: Multiple clinical chemistry analyte IVD, control	EN-1	Vk_20190607_06
12.06.2019	Aesculap AG	DISP.FLEECE DRAPE Model: F/GA419/GD417/GD421	MD: Multi-purpose surgical power tool system, line-powered	DE-1 EN-1	Vk_20190606_14
12.06.2019	Hologic, Inc.	Aptima Combo 2 Assay Model: Panther: 302923, 303094. Tigris: 301130	IVD: Multiple sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	EN-1	Vk_20190604_12
05.06.2019 (Updated12.06.2019)	TEC COM GmbH	TECOTHERM NEO Lot: all S/N: all	MD: Warming/cooling unit, patient	DE-1 FR-1 IT-1	Vk_20190529_05
11.06.2019	Teleflex Medical	Pleur Evac Model: S-1100-08LF / S-1200-08LF S-1200-08LF Lot: As per FSN appendix	MD: Thoracic suction collection container	DE-1 FR-1 IT-1 EN-1	Vk_20190605_12
11.06.2019	Pennine Healthcare Ltd	Feeding Tubes Lot: see fsn Levin Tubes Lot: see fsn Neleton Catheters Lot: see fsn Rectal Catheter Lot: see fsn Ryles tube Lot: see fsn Stomach Tubes Lot: see fsn Suction Catheters Lot: see fsn Medical Pack Lot: see fsn	MD: Nasoenteral tube MD: Gastrointestinal tube MD: Urine-sampling urethral catheter MD: Rectal tube MD: Nasogastric feeding tube MD: Tube, stomach evacuator MD: Tracheal suction catheter MD: General/plastic surgical procedure kit, non-medicated, single-use	EN-1 EN-2	Vk_20190603_13
11.06.2019	William Cook Europe ApS	Advance Enforcer Model: ASB5-35-50-6-4, ASB5-35-80-6-4, ASB5-35-135-6-4 Lot: 9234424, 9331618, 9212015, 9243035, 9320430, 9386804, 9338194, 9234423, 9278982	MD: Peripheral angioplasty balloon catheter, basic	DE-1 FR-1 IT-1 EN-1	Vk_20190603_07
28.05.2019 (Updated11.06.2019)	Philips Medical Systems	HeartStart MRx Defibrillator/ Monitor Model: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9, M3539A AC Power Module	MD: Rechargeable professional automated external defibrillator	DE-1 FR-1 IT-1 EN-1	Vk_20190524_13
17.12.2018 (Updated11.06.2019)	Ethicon Endo-Surgery, LLC	PROXIMATE HCS Hemorrhoidal Circular Stapler Model: PPH01, PPH03 Lot: See FSN	MD: Haemorrhoidal surgical stapler, single-use	DE-1.0 FR-1.0 EN-1.0	Vk_20181207_04
07.06.2019	Teleflex Medical	Sheridan Close Fitting Endotracheal Tube Sheridan Endotracheal Tube Sheridan HVT Endotracheal Tube Sheridan HVT EZ-Endo Endotracheal Tube Sheridan Preformed Endotracheal Tube Sheridan Uncuffed Endotracheal Tube	MD: Basic endotracheal tube, single-use MD: Basic endotracheal tube, single-use MD: Basic endotracheal tube, single-use MD: Basic endotracheal tube, single-use MD: Basic endotracheal tube, single-use MD: Basic endotracheal tube, single-use	DE-1 FR-1 IT-1 EN-1	Vk_20190528_15
05.06.2019 (Updated07.06.2019)	Thermo Fisher Scientific Oy	ALT/GPT (IFCC) Model: 981769 and 981361 Lot: all LDH (IFCC) Model: 981906 Lot: all LDH (SCE) Model: 981781 and 981383 Lot: all alpha-HBDH Model: 981380 Lot: all Creatine Kinase (IFCC) Model: 981828 and 981829 Lot: all Glucose (Hexokinase) without sample blank Model: 981779 and 981304 Lot: all	IVD: Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry IVD: Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometry IVD: Total lactate dehydrogenase (LDH) IVD, kit, enzyme spectrophotometry IVD: Alpha-hydroxybutyrate dehydrogenase IVD, kit, enzyme spectrophotometry IVD: Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry IVD: Glucose kit	DE-1 FR-1 IT-1 EN-1	Vk_20190523_15
28.05.2019 (Updated07.06.2019)	Medtronic Inc.	My Therapy App for Sacral Neuromodulation Therapy Model: A510 SW-Version: All	AIMD: Perineal orifice incontinence-control electrical stimulation system	DE-1 FR-1 EN-1	Vk_20190521_19
07.06.2019	Novak M d.o.o.	Therapy chair Zero G Model: TCZ-LUX S/N: 32260513-2018	MD: Therapy chair for long lasting treatment	DE-1 FR-1 EN-1	Vk_20190510_01
05.06.2019 (Updated06.06.2019)	Abbott	Alinity i BNP Calibrator Model: see FSN Lot: see FSN Alinity i BNP Control Model: see FSN Lot: see FSN	IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control	EN-1 EN-2	Vk_20190528_11
29.05.2019 (Updated06.06.2019)	Quidel Corporation	MicroVue C4d Fragment EIA Model: A008 Lot: 134472	IVD: Complement Activation	DE-1 EN-1	Vk_20190527_24
28.05.2019 (Updated06.06.2019)	Roche Diagnostics GmbH	Elecsys Syphilis (200 test/kit) Model: 07802960190	IVD: Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay	FR-1 EN-1	Vk_20190524_05
15.05.2019 (Updated06.06.2019)	Arkray Factory, Inc.	AUTION HYBRID AU-4050 Model: 14602 Lot: N/A S/N: All SW-Version: Ver.00-03 - Ver.00-16	IVD: Urine analyser IVD, laboratory, automated	DE-2 EN-1 EN-2	Vk_20190510_12
13.08.2018 (Updated06.06.2019)	Beckman Coulter, Inc.	UniCel DxH 900 Coulter Cellular Analysis System Model: see FSN S/N: All SW-Version: all UniCel DxH 600 Coulter Cellular Analysis System Model: see FSN S/N: All SW-Version: all UniCel DxH 800 Coulter Cellular Analysis System Model: see FSN S/N: All SW-Version: all	IVD: Haematological cell analyser IVD, automated IVD: Haematological cell analyser IVD, automated IVD: Haematological cell analyser IVD, automated	DE-1 DE-2 FR-1 FR-2 EN-1 EN-2	Vk_20180802_25
05.06.2019	Becton, Dickinson and Company	BD Microtainer tube Model: 365964, 365966, 365968, 365975, 365979, 365986, 365988, 365993 Lot: see FSN	IVD: Specimen container, general-purpose	EN-1	Vk_20190604_03
05.06.2019	Qiagen GmbH	QIAsymphony Filter Tips Model: 997024 Lot: 0605020019, 0605020020, 0635020002, 0635020003	IVD: SP Hardware + accessories + consumables + software	DE-1 FR-1 IT-1 EN-1	Vk_20190604_01
05.06.2019	Bard Access Systems Inc	EQUISTREAM, EQUISTREAM XK, GLIDEPATH Model: see FSN Lot: refer to FSN	MD: Double-lumen haemodialysis catheter, implantable	DE-1 FR-1 IT-1 EN-1	Vk_20190603_19
05.06.2019	Abbott Laboratories	ARCHITECT BNP Calibrator Model: see FSN Lot: see FSN ARCHITECT BNP Control Model: see FSN Lot: see FSN	IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control	EN-1	Vk_20190528_07
28.05.2019 (Updated05.06.2019)	Primed Halberstadt Medizintechnik GmbH	Sinapi Thoraxdrainage-Systeme Model: 70130 XS 50; 70132 XL1000SC Lot: See FSN	MD: Thoracic suction collection container	DE-1 FR-1 IT-1	Vk_20190527_17
28.05.2019 (Updated05.06.2019)	Abbott	Alinity ci-series System Control Module Model: 03R70-01 S/N: all SW-Version: Alinity ci Software V2.6.0 and V2.5.1 Alinity c Processing Module Model: 03R67-01	IVD: Chemiluminescent immunoassay analyser IVD, automated IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated	DE-1 FR-1 EN-1	Vk_20190523_10
28.05.2019 (Updated05.06.2019)	Phadia AB	EliA RF IgM Well Model: 14-5600-01 Lot: 0085/CJY2D	IVD: Rheumatoid factor IVD, kit, fluorescent immunoassay	DE-1 FR-1 EN-1	Vk_20190521_16
05.06.2019	Medtronic Inc.	Astra Model: X2DR01, X3DR01, X2SR01, X3SR01 Lot: all Azure Model: W2DR01, W2SR01 Lot: all Percepta Model: W1TR04, W4TR04 Lot: all Serena Model: W1TR05, W4TR05 Lot: all Solara Model: W1TR06, W4TR06 Lot: all	AIMD: Dual-chamber implantable pacemaker, rate-responsive AIMD: Single-chamber implantable pacemaker, rate-responsive AIMD: Cardiac resynchronization therapy implantable pacemaker AIMD: Cardiac resynchronization therapy implantable pacemaker AIMD: Cardiac resynchronization therapy implantable pacemaker	DE-1 FR-1 IT-1 EN-1	Vk_20190513_09
04.06.2019	GE Healthcare	Centricity Universal Viewer with Centricity PACS Foundations	MD: Medical image management system	DE-1 FR-1 IT-1 EN-1	Vk_20190603_15
04.06.2019	GE Vingmed Ultrasound AS	Vscan Extend	MD: General-purpose ultrasound imaging system	DE-1 FR-1 IT-1 EN-1	Vk_20190529_13
04.06.2019	GE Healthcare	Centricity Universal Viewer	MD: Medical image management system	DE-1 FR-1 IT-1 EN-1	Vk_20190529_12
04.06.2019	GE Medical Systems SCS	Senographe Pristina and Pristina Serena S/N: See FSN	MD: Stationary mammographic x-ray system, digital	DE-1 FR-1 IT-1 EN-1	Vk_20190529_10
04.06.2019	GE Healthcare Integrated IT Solutions	Centricity PACS-IW SW-Version: 3.6.0 to 3.7.3.9 SP1, SP2, SP3; 3.7.3 SPa10	MD: Radiology picture archiving and communication system application software	DE-1 FR-1 IT-1 EN-1	Vk_20190529_06
28.05.2019 (Updated04.06.2019)	Roche Diagnostics GmbH	cobas e 601 module, cobas e 602 module, MODULAR ANALYTICS E combinations, MODULAR ANALYTICS EVO E combinations AssayTip / AssayCup Model: 12102137001 Lot: 19817113, 19818113	IVD: Immunoassay Analyser IVD: IC&II Hardware + accessories + consumables + software	DE-1 FR-1 EN-1	Vk_20190522_14
21.05.2019 (Updated04.06.2019)	Medtronic Navigation Inc.	O-ARM 1000 Imaging System Model: See FSN S/N: All	MD: Portable general-purpose fluoroscopic x-ray system, digital	DE-1 FR-1 IT-1 EN-1	Vk_20190516_10
03.06.2019	EKOS Corporation inc.	EKOS Control System 4.0	MD: Ultrasound thrombolysis system control unit	DE-1 FR-1 IT-1 EN-1	Vk_20190527_03
28.05.2019 (Updated03.06.2019)	Roche Diagnostics GmbH	IGA-2 (Tina-quant IgA Gen.2) Model: 05219205190 Lot: 368756	IVD: Immunoglobulin A kit	DE-1 FR-1 EN-1	Vk_20190522_21
04.03.2019 (Updated03.06.2019)	MAQUET Cardiopulmonary GmbH	Pre-Bypass Filter Model: 70102.1039; 70102.1040; 70103.1084; 70103.1086 Lot: Please refer to Annex I S/N: N/A SW-Version: N/A	MD: Cardiopulmonary bypass system tubing set	DE-1.0 IT-1.0 EN-1.0	Vk_20190219_12
31.10.2018 (Updated30.05.2019)	Medtronic Navigation Inc.	Synergy Cranial, StealthStation Cranial Model: 9733763, 9735585 S/N: All of below listed software versions (see section 8) SW-Version: see section 8 comments for details	MD: Neurological stereotactic surgery system	DE-1.0 FR-1.0 IT-1.0 EN-1.0 EN-2.0	Vk_20181022_23
29.05.2019	Randox Laboratories Ltd	HUMAN ASSAYED MULTI-SERA Level 2 Model: HN1530 Lot: 1306UN, 1308UN, 1309UN	IVD: Multiple clinical chemistry analyte IVD, control	DE-1 FR-1 IT-1 EN-1	Vk_20190527_29
28.05.2019	PREVOR	DIPHOTERINE Model: MICRO-DAP, MINI-DAP	MD: Solution, irrigating, non-injectable	DE-1 FR-1 IT-1	Vk_20190524_01
28.05.2019	REGENYAL Laboratories S.R.L.	REGENYAL IDEA BODY 1x20ml	MD: Biological tissue reconstructive material	EN-1	Vk_20190522_09
28.05.2019	Edwards Lifesciences LLC	Intro-Flex Percutaneous Sheath Introducers Model: I355BF9 Lot: 61409005, 61409006, 61417169, 61446317, 61446318, 61446332, 61446333, 61468596, 61481228, 61481229, 61481230 and 61494718. S/N: N/A SW-Version: N/A	MD: Vascular catheter introduction set	DE-1 FR-1 IT-1 EN-1	Vk_20190521_21
16.05.2019 (Updated28.05.2019)	Leonhard Lang GmbH	Mindray defibrillation electrodes Model: MR62 Lot: See FSN Weinmann defibrillation electrodes Model: WM 40116, WM 45418 Lot: See FSN	MD: Electrodes, Cardiac, External Defibrillator MD: Electrodes, Cardiac, External Defibrillator	DE-1- Mindray DE-1- Weinmann FR-1 - Mindray FR-1 - Weinmann IT-1 - Mindray IT-1 - Weinmann EN-1- Mindray EN-1- Weinmann	Vk_20190516_06
28.05.2019	Abiomed Europe GmbH	Impella Guidewire 0.018" Model: 0052-3005	MD: Cardiac/peripheral vascular guidewire, single-use	DE-1 FR-1 IT-1	Vk_20190510_04
28.03.2019 (Updated28.05.2019)	B. Braun Melsungen AG	Connection Lead SP (12V) Model: 8713231 Lot: From 40/17 to 43/18 and From 07/19 to 16/19	MD: Electrical-only medical device connection cable, reusable	DE-1 DE-2 EN-1	Vk_20190325_04
11.12.2018 (Updated28.05.2019)	LivaNova USA, Inc.	VNS Therapy SenTiva Generator Model: 1000 S/N: All below 100'000	AIMD: Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system	DE-1 DE-2 FR-1 FR-2 IT-1 IT-2 EN-1 EN-2	Vk_20181205_01
22.05.2019 (Updated27.05.2019)	bioMérieux SA	VIDAS NT-proBNP2 Model: 30458 Lot: 1007078560	IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, enzyme immunoassay (EIA)	FR-1 EN-1	Vk_20190517_03
27.05.2019	Gambro Lundia AB	Prismaflex System Model: 114870, 113874, 107493, 106913, 955052, 114489, 113082 S/N: All serial numbers with software 8.10 SW-Version: 8.10	MD: Haemodialysis system, institutional	DE-1 FR-1	Vk_20190515_08
22.05.2019 (Updated27.05.2019)	Olympus Medical Systems Corp.	EVIS LUCERA DUODENOVIDEOSCOPE Model: TJF-160VR; N1425530 & E0425505 S/N: All	MD: Flexible video duodenoscope, reusable	DE-1 DE-2 FR-1 FR-2 IT-1 IT-2 EN-1 EN-2	Vk_20190507_12
27.05.2019	Cook Endoscopy	Hemospray Endoscopic Hemostat Model: HEMO-7-EU, HEMO-10-EU	MD: Inorganic haemostatic agent, sterile	DE-1 FR-1 IT-1	Vk_20190205_11
27.05.2019	Cook Incorporated	Vacuum Pump KMAR-5200 Lot: All lots	MD: General-purpose suction system, line-powered	DE-1.0 FR-1.0 IT-1.0	Vk_20180319_01
26.03.2018 (Updated27.05.2019)	Gambro Dialysatoren GmbH	Ultrafilter U9000 Model: 112062 Lot: From 6-1907-H-01 and higher	MD: Microbial water purification filter, sterilizable	DE-1.0 DE-2.0 FR-2.0	Vk_20180314_01
22.05.2019 (Updated24.05.2019)	Abbott	Alinity c Complement C3 Reagent Kit Model: 09P5620 Lot: all Lots Alinity c Immunoglobulin A Reagent Kit Model: 09P6120 Lot: all Lots Alinity c Immunoglobulin G Reagent Kit Model: 09P6220 Lot: all Lots Alinity c Immunoglobulin M Reagent Kit Model: 09P6320 Lot: all Lots Alinity c Apolipoprotein A1 Reagent Kit Model: 09P4620 Lot: all Lots Alinity c Complement C4 Reagent Kit Model: 09P5720 Lot: all Lots Alinity c Haptoglobin Reagent Kit Model: 09P5920 Lot: all Lots Alinity c Apolipoprotein B Reagent Kit Model: 09P4720 Lot: all Lots Alinity c Transferrin Reagent Kit Model: 08P3820 Lot: all Lots	IVD: Complement components C3/C3c IVD, reagent IVD: Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry IVD: Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry IVD: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry IVD: Apolipoprotein A-I (Apo A1) IVD, reagent IVD: Complement components C4/C4c IVD, reagent IVD: Haptoglobin IVD, reagent IVD: Apolipoprotein B (Apo B) IVD, reagent IVD: Transferrin IVD, kit, nephelometry/turbidimetry	DE-1 FR-1 EN-1	Vk_20190520_07
24.05.2019	Neuromedex GmbH	SECURODRAIN / NeuroVac Silikon-Flachdrainage Model: 21-0411 Lot: 81038	MD: Drains, Wound	DE-1 FR-1	Vk_20190514_12
22.05.2019 (Updated24.05.2019)	bioMérieux	Chocolate agar + PolyViteX Model: 43109 Lot: 1007089110 S/N: N/A SW-Version: N/A	IVD: Factors X/V chocolate agar culture medium IVD	DE-1 FR-1 EN-1	Vk_20190514_07
24.05.2019	Getinge - Maquet GmbH	QUADROX-i Neonatal Microporous Membrane Oxygenator Model: 701049279 Lot: 92261621	MD: Extracorporeal membrane oxygenator	FR-1 EN-1	Vk_20190510_19
23.01.2019 (Updated24.05.2019)	Dako North America, Inc.	Dako Autostainer Slide Racks Model: S3704	IVD: Microscope slide stainer IVD	DE-1 FR-1 EN-1	Vk_20190117_12
01.05.2019 (Updated23.05.2019)	DiaMed GmbH	IH-QC1 Model: 08710; 009321 Lot: All lots currently in date	IVD: Multiple immunohaematology test IVD, control	DE-1 FR-1 IT-1 EN-1	Vk_20190426_12
22.05.2019	Fluoron GmbH	Brilliant Peel Model: G-81010 Lot: BP 0.5S 300718	MD: Eye dye	DE-1 FR-1 IT-1	Vk_20190522_07
22.05.2019	Siemens Healthcare Diagnostics Inc.	Atellica and ADVIA Creatine Kinase (CK_L) Reagent Model: see FSNs Lot: see FSNs	IVD: Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry	DE-1 (Advia) DE-1 (Atellica) EN-1 (Advia) EN-1 (Atellica)	Vk_20190516_12
22.05.2019	Qiagen GmbH	RNeasy DSP FFPE Kit Model: 73604 Lot: 163016105	IVD: Other Other Genetic Tests	DE-1 FR-1 IT-1	Vk_20190514_13
14.05.2019 (Updated22.05.2019)	Olympus Medical Systems Corp.	OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE Model: TJF-Q190V S/N: All OLYMPUS EVIS LUCERA ELITE DUODENOVIDEOSCOPE Model: TJF-Q290V S/N: All	MD: Flexible video duodenoscope, reusable MD: Flexible video duodenoscope, reusable	DE-1 FR-1 IT-1 EN-1	Vk_20190510_13
07.05.2019 (Updated22.05.2019)	Covidien LLC	Mahurkar Triple Lumen Catheter Model: see FSN Lot: All Mahurkar Dual Lumen Catheter Model: see FSN Lot: All Argyle Single Lumen Catheter Model: see FSN Lot: All	MD: Triple-lumen haemodialysis catheter MD: Double-lumen haemodialysis catheter, nonimplantable MD: Single-lumen haemodialysis catheter, peripheral vascular	DE-1 FR-1 EN-1	Vk_20190506_09
21.05.2019	Terumo Cardiovascular Systems	Electronic Patient Gas System Flowmeter - APS1 Model: 801188 Lot: All March 29, 2019	MD: Cardiopulmonary bypass system, roller type	DE-1 FR-1 IT-1 EN-1	Vk_20190516_16
21.05.2019	Micro-Mega SA	X-Cid2 Model: X-CID2 230V EUR EMB;51100003 S/N: Unknown	MD: Dental handpiece maintenance unit	DE-1 FR-1 IT-1 EN-1	Vk_20190516_07
21.05.2019	TORNIER SAS	Non sterile pin guide Model: MWE157, MWB319, MJU093 Lot: 18B792, 18C696, 18D493, 19A141	MD: Drilling power tool attachment, basic	DE-1 FR-1 IT-1	Vk_20190514_01
20.05.2019	Xhale Assurance, Inc	Nasal Alar SpO2 Sensor Model: 0303, 0201-A01 Lot: 101624 - 101842	MD: Pulse oximeter probe, single-use	DE-1 FR-1 EN-1	Vk_20190513_04
17.05.2019	Sinapi Biomedical (Pty) Ltd	Sinapi Chest Drain Model: XL200, XL200S, XL200SC, XL1000, XL1000S, XL1000SC, XL2000S, XL2000SD	MD: Pleural drainage system	EN-1	Vk_20190516_09
23.04.2019 (Updated17.05.2019)	Philips Medical Systems	IntelliVue MX40 Patient Monitor Model: See FSN SW-Version: See FSN	MD: Single-patient physiologic monitoring system	DE-1 DE-2 FR-1 FR-2 EN-1 EN-2	Vk_20190423_16
03.04.2019 (Updated17.05.2019)	Randox Laboratories Ltd	G-6-PDH Control Deficient and Normal Model: PD2617, PD2618 Lot: 687PD, 700PD, 715PD, 676PD, 701PD, 716PD G-6-PDH Model: PD410 Lot: all	IVD: Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control IVD: Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry	DE-1 FR-1 IT-1 IT-2 EN-1 EN-2	Vk_20190401_27
05.12.2018 (Updated17.05.2019)	Roche Diagnostics GmbH	Bilirubin Total Gen.3 Model: see FSN Lactate Model: see FSN LACT2 Model: see FSN IgM-2 Model: see FSN	IVD: Total bilirubin IVD, kit, spectrophotometry IVD: Lactate IVD, kit, enzyme spectrophotometry IVD: Lactate IVD, kit, enzyme spectrophotometry IVD: Immunoglobulin M kit	DE-1 DE-2 FR-1 FR-2 IT-1 IT-2 EN-1 EN-2 A EN-2 B	Vk_20181203_01
28.06.2018 (Updated17.05.2019)	Radiometer Medical ApS	ABL800 Model: 393-800, 393-801 S/N: All SW-Version: Software versions 6.14 to 6.18	IVD: Metabolic profile clinical chemistry analyser IVD, stationary, automated	DE-1 DE-2 FR-1 FR-2 IT-1 IT-2 EN-1 EN-2	Vk_20180620_03
16.05.2019	I.T.S. GmbH	Rim Platte, 10-Loch, Links, PRS RX System Model: 21206-10 Lot: 26/F42778	MD: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile	DE-1 EN-1	Vk_20190509_07
16.05.2019	Von Ardenne Institut für Angewandte Medizinische Forschung GmbH	IRATHERM1000 S/N: 001/01/94 bis 118/12/15 SW-Version: V4.1	MD: Warming Units, Patient	DE-1 FR-1 EN-1	Vk_20190508_06
16.05.2019	Fluoron GmbH	F-Decalin Model: G-80115, G-80117 Lot: See FSN F-Octane Model: G-80315, G-80317 Lot: See FSN	MD: Vitreous/aqueous humour replacement medium, intraoperative MD: Vitreous/aqueous humour replacement medium, intraoperative	DE-1 FR-1 IT-1 EN-1	Vk_20190426_07
12.04.2019 (Updated16.05.2019)	Medset Medizintechnik GmbH	PADSY-Holter Model: Sirius, Antares Lot: AAG118111, AAG118121 SW-Version: from Version 7.5a	MD: Holter ECG Analysis System	DE-1 DE-2 FR-1 IT-1 EN-1 EN-2	Vk_20190405_12
15.05.2019	Siemens Healthcare GmbH	ARTIS Icono Biplane S/N: 180003, 180004	MD: Stationary angiographic x-ray system, digital	DE-1	Vk_20190513_10
14.05.2019	Philips Medical Systems Ultrasound Inc.	EPIQ Ultrasound System Model: 795200, 795201, 795202, 795203, 795204, 795205, 795206, 795207, 795208, 795209, 795210, 795211, 795117, 795118, 795119, 795218, 795231, 795232, 795233, 795120 Affiniti Ultasound System Model: 795200, 795201, 795202, 795203, 795204, 795205, 795206, 795207, 795208, 795209, 795210, 795211, 795117, 795118, 795119, 795218, 795231, 795232, 795233, 795120	MD: General-purpose ultrasound imaging system MD: General-purpose ultrasound imaging system	DE-1 FR-1 IT-1 EN-1	Vk_20190510_22
14.05.2019	Medical Service GmbH	Mobile SL, Ergothan Model: 580012G CH 12, 580014G CH 14, 580114G CH 14 Lot: 1745228, 17/45/228, 1743203, 17/43/203, 1817202, 18/17/202, 1738207, 17/38/207	MD: Single-administration urethral drainage catheter	DE-1 FR-1 IT-1 EN-1	Vk_20190509_06
14.05.2019	Pfizer Consumer Health Care	ThermaCare Lot: S00639	MD: Exothermic heat therapy pack	DE-1 EN-1	Vk_20190508_08
14.05.2019	Becton Dickinson and Company Limited	BD PhaSeal Secondary Set Model: C61; 515302 Lot: 1011102, 1011095, 1011186, 1011412, 1011464, 1011580, 1011753, 1011786, 1011787	MD: Basic intravenous administration set	DE-1	Vk_20190507_13
14.05.2019	MSP Medizintechnik GmbH	HSO Safeheat Wärmehandschuh Model: HSOWHAND01	MD: Wärmehandschuh	DE-1 EN-1	Vk_20190423_15
13.05.2019	SenTec AG	Membrane Changer Model: MC-R Lot: See FSN Membrane Changer Insert Model: MC-I Lot: See FSN Membrane Changer Set Model: MC-SET Lot: See FSN SenTec Standard Starter Set Model: SSET Lot: See FSN SenTec Standard Starter Set (without Service Gas) Model: SSET_nG Lot: See FSN Sentec Neonatal Starter Set without gas Model: SSET-N_nG Lot: See FSN SenTec Neonatal Starter Set Model: SSET-N Lot: See FSN	MD: Pulse Co-oximeter probe, reusable MD: Pulse Co-oximeter probe, reusable MD: Pulse Co-oximeter probe, reusable MD: Transcutaneous blood gas monitoring system MD: Transcutaneous blood gas monitoring system MD: Transcutaneous blood gas monitoring system MD: Transcutaneous blood gas monitoring system	DE-1 FR-1 IT-1 EN-1	Vk_20190503_18
08.05.2019 (Updated13.05.2019)	Abbott Laboratories	ARCHITECT c4000 / c8000 / c16000 Mixer Model: 02P24; 01G06; 03L77; S/N: All Serial numbers	IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated	DE-1 FR-1 IT-1 EN-1	Vk_20190503_13
13.05.2019	Fresenius Vial	Orchestra Base Intensive and Orchestra Base Primea Model: Z0812XX and Z0813XX (see FSA enclosed)	MD: Infusion pump management unit, mobile	DE-1 FR-1 EN-1	Vk_20190430_08
13.05.2019	BEAVER-VISITEC INTERNATIONAL, INC	BVI OPHTHALMIC FLUID CONTROL SPONGES Model: 90900, 90910, 223620, 223621, 400200, 400207, 581047,223622, 400117, 400210, 581076 Lot: Various	MD: various	DE-1 FR-1 IT-1 EN-1	Vk_20190429_20
09.05.2019 (Updated13.05.2019)	Beckman Coulter, Inc.	Access Free T3 Model: A13422 Lot: all Access Free T4 Model: 33880 Lot: all Access Total T3 Model: 33830 Lot: all Access Thyroglobulin Assay Model: 33860 Lot: all Access GI Monitor Model: 387687 Lot: all Access Thyroglobulin Antibody II Model: A32898 Lot: all	IVD: Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay IVD: Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay IVD: Reverse triiodothyronine (reverse T3) IVD, kit, chemiluminescent immunoassay IVD: Thyroglobulin IVD, kit, chemiluminescent immunoassay IVD: Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA) IVD: Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay	DE-1 FR-1 EN-1	Vk_20190426_19
28.02.2019 (Updated13.05.2019)	TransEnterix Italia S.r.l.	RADIA Adapter and Shaft for Articulated Instrument Model: X9000009, X0005216 Lot: All S/N: All	MD: Robotic surgical system	DE-1 FR-1 IT-1 IT-2	Vk_20190220_02
10.05.2019	Institut Straumann AG	Straumann TempImplant ø 2.0mm, L 12.0mm, Ti Model: 80372SV4 Lot: VK308	MD: Screw endosteal dental implant, one-piece	DE-1 EN-1	Vk_20190503_05
09.05.2019	Terumo Medical Corporation	SOLOPATH Re-Collapsible Balloon Access System Model: SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435 Lot: all Lots (see FSN 1a) SOLOPATH Expandable Model: STFI-1425, STFI-1435, STFI-1625,STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Lot: all Lots (see FSN 1a) Portico Solo Re-Collapsible Access System Model: PRTSOLO-19,PRTSOLO-20 Lot: all Lots (see FSN 1b)	MD: Vascular catheter introduction set MD: Vascular catheter introduction set MD: Vascular catheter introduction set	DE-1a DE-1b FR-1a FR-1b IT-1a IT-1b EN-1a EN-1b	Vk_20190506_15
09.05.2019	Mathys Ltd Bettlach	twinSys impactor with offset Model: 51.34.0446 Lot: 6054487, 6061532, 6063726, 6065504, 6066616, 6067637, 6068893, 6070147	MD: Joint prosthesis implantation kit, reusable	DE-1 FR-1 EN-1	Vk_20190502_04
09.05.2019	GE Medical Systems SCS	Achilles EXP II S/N: See FSN	MD: Bone absorptiometric ultrasound system	DE-1 EN-1	Vk_20190430_13
09.05.2019	Philips Medical Systems	SureSigns VS Series Monitor Model: 863069, 863070, 863071, 863072, 863073, 863074, 863283, 863286 S/N: 863071, 863072, 863073, 863074, 863283, 863286 SW-Version: Up to and including A.07.32	MD: Single-patient physiologic monitoring system	DE-1 FR-1 IT-1 EN-1	Vk_20190429_12
09.05.2019	OLEA MEDICAL S.A.S.	Olea Sphere SW-Version: V3.0	MD: MRI and CT image processing software	DE-1 FR-1 IT-1 EN-1	Vk_20190426_10
08.05.2019	Edwards Lifesciences LLC	PASCAL System Model: 10000IS; 10000GS Lot: All PASCAL Systems distributed	MD: Mitral valve clip	DE-1 EN-1	Vk_20190506_17
08.05.2019	Carestream Health Inc	OnSight 3D Extremity System S/N: Range 10013 - 20022	MD: Limited-view-field CT system	FR-1 EN-1	Vk_20190503_09
07.05.2019 (Updated08.05.2019)	Cook Incorporated	Kwart Retro-Inject Ureteral Stent Set Model: 003500, 003600, 003700, 003800, AQ-003500, AQ-003600, AQ-003700 Lot: All Salle Intraoperative Pyeloplasty Stent Set Model: SIPSF-040018-56-6, SIPSF-040018-59, SIPSF-050018-59 Lot: All	MD: Polymeric ureteral stent MD: Nephrostomy catheter	DE-1 FR-1 IT-1 EN-1	Vk_20190502_06
08.05.2019	Siemens Healthcare GmbH	Artis Zee S/N: systems delivered since Mai 2018 Artis Q/Q.zen S/N: systems delivered since Mai 2018	MD: Stationary angiographic x-ray system, digital MD: Stationary angiographic x-ray system, digital	FR-1 EN-1	Vk_20190501_02
08.05.2019	Getinge Disinfection AB	Getinge 86-series Model: S-8666, S-8668 S/N: All devices delivered from Manufacturing Site after 28.11.2018	MD: Washer, decontamination	DE-1 EN-1	Vk_20190425_02
30.04.2019 (Updated08.05.2019)	Maquet SAS	VOLISTA Model: STANDOP & TRIOP	MD: Operating light	DE-1 FR-1 EN-1	Vk_20190424_08
07.05.2019	Gambro Industries	MARS Treatment Kit Model: 800540 Lot: See FSN OXIRIS S Model: 955503 Lot: See FSN SEPTEX Set Model: 112017 Lot: See FSN PRISMAFLEX set Model: 107144, 107636, 107640	MD: Bound solute dialysis system component set MD: Haemofilter MD: Haemofilter MD: Haemofilter	DE-1 FR-1	Vk_20190501_01
02.05.2019 (Updated07.05.2019)	Abbott Vascular	MitraClip XTR Delivery System Model: CDS0602-XTR Lot: All lots	MD: Mitral valve tissue repair system	DE-1 FR-1 IT-1 EN-1	Vk_20190430_01
07.05.2019	Peter Brehm Chirurgie-Mechanik e.K.	TRIAL Titanium Shell left with strap 60 mm Model: 54860-15-1 Lot: 15006263	MD: Trial Prostheses, Joint, Hip	DE-1 EN-1	Vk_20190426_17
18.04.2019 (Updated07.05.2019)	Leonhard Lang GmbH	Schiller Defibrillationselektrode Model: 0-21-0003, 0-21-0020, 2.155061, 2.155065, 2.155063, 0-21-0037, 2.155067, 0-21-0040 Lot: see FSN SW-Version: n.z.	MD: Electrodes, Cardiac, External Defibrillator	DE-1 FR-1 IT-1 EN-1	Vk_20190411_20
02.05.2019 (Updated06.05.2019)	Tristel Solutions Limited	Tristel Rinse Wipe Model: TSL030301 Lot: 832400/1	MD: Medical device disinfection wipe	DE-1 FR-1 IT-1 EN-1	Vk_20190429_14
01.05.2019 (Updated06.05.2019)	Standard Diagnostics Inc.	SD BIOLINE Chikungunya IgM Model: 46FK10 Lot: 46ADB005A, 46ADB005B, 46ADC001A, 46ADC002A, 46ADC002B, 46ADC003A, 46ADC003B	IVD: Other Viral Antigen/Antibody Detection	FR-1 EN-1	Vk_20190429_03
06.05.2019	Aesculap AG	Caiman Maryland non Articulat.D5/360MM Model: PL770SU Lot: 52481830	MD: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use	DE-1 EN-1	Vk_20190425_17
02.05.2019 (Updated06.05.2019)	BEAVER-VISITEC INTERNATIONAL, INC	Visiwipe Instrument Wipe 7.3 x 7.3 cm Model: 581047 Lot: 18B0431; 18B0542; 18C0753; 18F1889; 18J2671	MD: Medical device disinfection wipe	DE-1 FR-1 EN-1	Vk_20190405_09
12.12.2018 (Updated06.05.2019)	Randox Laboratories Ltd	Calcium Model: CA3871, CA8309, CA8021 Lot: not lot specific	IVD: Calcium (Ca2+) IVD, kit, spectrophotometry	DE-1 DE-2 DE-3 FR-1 FR-2 FR-3 EN-1 EN-2	Vk_20181204_06
01.05.2019 (Updated03.05.2019)	Axis-Shield Diagnostics Limited	Alere NT-proBNP Control Model: 2R10-10, 04S7910 Lot: 902922185, 10777UP00, 10805UP00 Alere NT-pro BNP Calibrator Model: 2R10-01, 04S7901 Lot: 902922220, 10774UP00, 10801UP00	IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator	DE-1 FR-1 EN-1	Vk_20190425_14
03.05.2019	SenoRx, Inc.	EnCor Breast Biopsy Probe Model: ECP0110G, ECP017G, ECP0110GV, ECP017GV, ECP0112G, ECP0112GV Lot: See FSN	MD: Mammographic stereotactic biopsy system	DE-1 FR-1 IT-1 EN-1	Vk_20190425_04
03.05.2019	Edwards Lifesciences LLC	Miller Balloon Atrioseptostomy Catheter Model: 830515F Lot: All lots Fogarty Dilation Atrioseptostomy Catheter Model: 830705F Lot: All lots	MD: Cardiac septostomy catheter, balloon MD: Cardiac septostomy catheter, balloon	DE-1 FR-1 IT-1 EN-1	Vk_20190425_01
23.04.2019 (Updated03.05.2019)	MEDTEC, Inc. dba CIVCO Medical Solutions and CIVCO Radiotherapy	Tilting Head Fixation System (Solstice) Model: CHS03, CHS04, CHS03K, CHS03GK, CHS04K and CHS04GK Lot: CHS03: M602380 - DOM 6/27/18 M680480 - DOM 9/5/18 M847590 - DOM 10/29/18 M870360 -DOM 2/26/19 CHS04: M680530 - DOM 9/5/18 M789110 - DOM 10/3/18	MD: Radiological headrest	DE-1 FR-1 IT-1 EN-1	Vk_20190418_11
24.04.2019 (Updated03.05.2019)	Linkage Biosciences Inc.	SureTyper Software Model: STTPGRX SW-Version: v6.0.0	IVD: Diagnostics & Clinical Interpretation Supporting Software	DE-1 FR-1 EN-1 EN-1_2	Vk_20190417_03
08.04.2019 (Updated03.05.2019)	Grifols Diagnostic Solutions Inc.	Procleix HEV Assay Model: PRD-03042, PRD-02789	IVD: Hepatitis E virus nucleic acid IVD, kit, nucleic acid technique (NAT)	DE-1 IT-1 EN-1	Vk_20190408_04
30.04.2019 (Updated02.05.2019)	William Cook Europe ApS	Zenith Alpha Thoracic Endovascular Graft Model: ZIMB-xx-xxx Lot: see attachment 1	MD: Synthetic vascular graft	DE-1 EN-1	Vk_20190426_04
24.04.2019 (Updated02.05.2019)	Biokit S.A.	QUANTIA RF Model: 6K44-01 Lot: 01518H000	IVD: Rheumatoid Factors	DE-1 FR-1 IT-1 EN-1	Vk_20190418_05
25.04.2019 (Updated02.05.2019)	Steripack SA	Safety pin no. 3, 1 piece per pouch Model: 331016S Lot: 1810069	MD: Surgical instrument clip	DE-1 FR-1 EN-1	Vk_20190415_03
01.05.2019	Quidel Corporation	MicroVue DPD EIA Model: 8007 Lot: 132254 SW-Version: N.A.	IVD: Deoxypyridinoline	EN-1	Vk_20190429_19
30.04.2019	Boston Scientific Corporation	Xenform Tissue Repair Matrix Model: M0068302410, M0068302430, M0068302450, M0068302470 Pinnacle LITE Pelvic Floor Repair Kit Model: M0068318150 Polyform Synthetic Mesh Model: M0068402400, M0068402410 Uphold LITE Vaginal Support System with Capio SLIM Model: M0068318170	MD: Pelvic organ prolapse/stress urinary incontinence surgical mesh MD: Pelvic organ prolapse surgical mesh, synthetic polymer MD: Pelvic organ prolapse surgical mesh, synthetic polymer MD: Pelvic organ prolapse surgical mesh, synthetic polymer	DE-1 FR-1 IT-1 EN-1	Vk_20190429_16
30.04.2019	Edwards Lifesciences LLC	EV1000 Clinical Platform System Model: EV1000A, EV1000NI S/N: ALL	MD: Patient monitoring system	DE-1 FR-1 IT-1 EN-1	Vk_20190424_07
30.04.2019	TVA Medical, Inc.	everlinQ 4 endoAVF System Model: ELQ-002 Lot: S0043	MD: Vascular guide-catheter, single-use	DE-1	Vk_20190418_13
24.04.2019 (Updated30.04.2019)	Covidien LLC	Argyle Universal Green Bubble Tubing Model: 8888230201 Lot: See FSN Argyle Thoracic Catheter Model: 8888570549, 8888571059 Lot: See FSN Aryle Flexible Yankauer Catheter Model: 8888501007, 8888501023, 8888504001 Lot: See FSN Dover Silicone Foley Catheter Model: 8887605122, 8887605163, 8887605205, 8887630245 Lot: See FSN	MD: Suction system tubing, single-use MD: Multi-purpose percutaneous drainage catheter MD: Suction system catheter, general-purpose MD: Indwelling urethral drainage catheter	DE-1 FR-1 EN-1	Vk_20190416_07
24.04.2019 (Updated29.04.2019)	Abbott	Alinity c Cuvette Segment Model: 04S47-01 Lot: N/A S/N: all SW-Version: N/A Alinity c Processing Module Model: 03R67-01	IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated	DE-1 FR-1 EN-1	Vk_20190417_05
16.04.2019 (Updated29.04.2019)	Ortho Clinical Diagnostics Inc.	VITROS Chemistry Products CK Slides Model: 8478034, 8479396 Lot: see fsn	IVD: Total creatine kinase (CK) IVD, reagent	DE-1 EN-1	Vk_20190411_03
26.04.2019	Siemens Healthcare GmbH	syngo.via Model: 10496180 - 10561669 and 10561495 SW-Version: several	MD: Radiology picture archiving and communication system application software	DE-1 FR-1	Vk_20190416_16
26.04.2019	Smiths Medical ASD Inc	Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes Model: BRC270, BRC275, BRC280, BRC285, BRC290, BRCA70, BRCA75, BRCA80, BRCA85, BRCA90 Lot: ALL S/N: N/A SW-Version: N/A	MD: Tracheostomy tube cannula, single-use	DE-1 EN-1	Vk_20190221_10
25.04.2019	Philips Medical Systems DMC GmbH	MobileDiagnost wDR Model: 712001,712002, 712004, 712005 S/N: all	MD: Radiographic unit, mobile	DE-1 FR-1 IT-1 EN-1	Vk_20190417_13
25.04.2019	Accuray Incorporated (Madison)	CyberKnife SW-Version: 11.x	MD: Linear accelerator system	DE-1 FR-1 IT-1 EN-1	Vk_20190416_20
25.04.2019	Willy Rüsch GmbH	Lasertube Model: 102004-000040, 102004-000050, 102004-000060, 102004-000070, 102004-000080 Lot: See FSN	MD: Laser-resistant endotracheal tube	DE-1 FR-1 IT-1 EN-1	Vk_20190411_05
25.04.2019	OHST Medizintechnik AG	Ceramic femoral heads & Ceramic cup inserts Hip prosthesis, internal, femoral component	MD: Acetabulum prosthesis MD: Hip prosthesis, internal, femoral component	DE-1.0 IT-1.0 EN-1.0	Vk_20181214_25
24.04.2019	Occlutech GmbH	Occlutech Delivery Set Model: 51ES006, 51ES007, 51ES008, 51ES009, 51ES010, 51ES011	MD: Cardiac occluder delivery kit	DE-1 FR-1 IT-1 EN-1	Vk_20190417_10
24.04.2019	Thermo Fisher Scientific Microbiology Basingstoke	ThermoScientific Oxoid Ceftriaxone 32 M.I.C.E. Model: MA0122D & F Lot: 2380270; 2341066	IVD: MICROBIOLOGY (CULTURE)	DE-1 FR-1 EN-1	Vk_20190416_21
24.04.2019	Thermo Fisher Scientific Microbiology Perth	Oxoid Bacillus Cereus Medium (MYP) Model: PO5133A Lot: 2635614	IVD: MICROBIOLOGY (CULTURE)	DE-1 EN-1	Vk_20190416_09
23.04.2019	AngioDynamics	Solero Microwave Tissue Ablation System Generator Model: H787127400000, H7877001060010, H7877001060020, H7877001060030 S/N: multiple	MD: Microwave hyperthermia system applicator, intracorporeal	DE-1 FR-1 IT-1 EN-1	Vk_20190423_26
23.04.2019	Philips Medical Systems Nederland BV	Ingenia Ambition S Model: 781359 Ingenia Ambition X Model: 781356	MD: Full-body MRI system, superconducting magnet MD: Full-body MRI system, superconducting magnet	DE-1 EN-1	Vk_20190416_26
23.04.2019	Topcon Corporation	IMAGEnet 6 SW-Version: 1.00, 1.01, 1.02, 1.10, 1.11, 1.12, 1.13, 1.14, 1.15, 1.16, 1.17, 1.18, 1.19, 1.20, 1.21, 1.22, 1.22.1, 1.23, 1.24	MD: Information Systems, Picture Archiving and Communication	DE-1 FR-1 IT-1 EN-1	Vk_20190416_24
23.04.2019	3M Health Care	3M Reston Self-Adhering Foam Model: 1560M and 1561H Lot: for 1560M: 3337GM; 3337HY; 3337PK; 3337T4; 3337W8; 3337XE; 33393N; 33394H; 33396C; 3339CM; 3339FC; 333AK7; 333AM6; 333AT3; 333BTX; 333BYW; 333EA7; 333ECJ; 333EEK; 333ETK; 333EYJ; 333KR7; 333KTE; 333KYR; 333LCX; 333LGA; 333N5T; 333N93; 333NLC for 1561H: 2	MD: Multifunction body cushion	DE-1 FR-1 IT-1 EN-1	Vk_20190411_13
10.04.2019 (Updated23.04.2019)	Siemens Healthcare GmbH	Cios Alpha Model: Cios Alpha VA30 Systems	MD: Portable general-purpose fluoroscopic x-ray system, digital	DE-1 FR-1 EN-1	Vk_20190403_13
10.04.2019 (Updated23.04.2019)	Siemens Healthcare GmbH; Business Area Advanced Therapies	Cios Spin	MD: Portable general-purpose fluoroscopic x-ray system, digital	DE-1 EN-1	Vk_20190403_08
02.04.2019 (Updated23.04.2019)	Medtronic Inc.	Activa Clinician Programmer Application Model: A610 S/N: All SW-Version: 1.0.3470	AIMD: Multiple active implantable device programmer	DE-1 FR-1 IT-1 EN-1	Vk_20190402_02
25.04.2018 (Updated23.04.2019)	Roche Diagnostics GmbH	Vitamin D total II, Elecsys Vitamin D total II Model: 07464215190, 07028148190 Lot: n.a.	IVD: 25-Hydroxy vitamin D3 IVD, reagent	DE-1 DE-2 DE-3 FR-1 FR-2 FR-3 IT-3 EN-1 EN-2 EN-3	Vk_20180418_01
21.08.2017 (Updated18.04.2019)	Covidien LLC	Emprint Percutaneous Antenna with Thermosphere Technology Model: CA15L1, CA20L1, CA30L1, CA15L2, CA20L2, CA30L2 Lot: See FSN Emprint SX Navigation Antenna with Thermosphere Technology Model: CA15L2N, CA20L2N, CA30L2N	MD: Microwave hyperthermia system applicator, intracorporeal; Microwave ablation system probe MD: Microwave ablation system probe	DE-1 DE-2 DE-3-bestehende Kunden DE-3-neue Kunden FR-1 FR-2 FR-3-clients existants FR-3-nouveaux clients IT-1 IT-2 IT-3 EN-1 EN-2 EN-3	Vk_20170814_11
16.04.2019 (Updated17.04.2019)	Olympus Surgical Technologies America	Diego Elite Power Console Model: EGMDCONS100 SW-Version: UIC version 2.3.9.0 and RTC version 00.01.23 Diego Elite Shaver Blade Model: EGBB2000SA, EGMM4000SS, EGBB4000SS, EGBB4000SC, EGBB4040XS, EGBB4040XC, EGBB4040SS, EGBB4040SC, EGMB4000SS Lot: All	MD: Pneumatic arthroscopic shaver system control unit MD: Metal/carbide ENT bur, single-use	DE-1 EN-1	Vk_20190409_23
17.04.2019	AtriCure, Inc.	Cobra Fusion Ablation System Model: 700-001S, 700-001MI, 700-002, 700-003	MD: Electrosurgical system	EN-1.0	Vk_20190128_04
21.10.2018 (Updated17.04.2019)	Endologix International Holdings B.V.	Nellix, Endovascular Aneurysm Sealing System Model: N10-100, N10-110, N10-120, N10-130, N10-140, N10-150,N10-160, N10-170, N10-180, N10-190, N10-200 NP-002; NP-004; NP-001; NP-003; NP-005; NX-001, NX-002a;N/A Lot: N/A S/N: N/A SW-Version: N/A	MD: Abdominal aorta endovascular stent-graft	DE-1.0 FR-1.0 IT-1.0 EN-1.0	Vk_20181015_13
16.04.2019	Drägerwerk AG & Co.KGaA	Oxylog VE300 Model: 5790200 SW-Version: NA	MD: Transport electric ventilator	DE-1	Vk_20190415_07
16.04.2019	Cook Incorporated	Pericardiocentesis Catheter Set Model: C-PCS-850 Lot: 7703324, NS7703501, NS7703502, NS7703503, NS7704718 Thoracentesis Set Model: C-THS-850 Lot: NS7662071	MD: Pericardiocentesis catheter MD: Pleural drainage system	DE-1 FR-1 EN-1	Vk_20190412_01
16.04.2019	Integra LifeSciences (Ascension Orthopedics)	Movement Great Toe System Model: MGT-890-10MT, MGT-890-20MT, MGT-890-30MT, MGT-890-40MT Lot: All	MD: Total metatarsophalangeal joint prosthesis, one-piece	DE-1 FR-1 EN-1	Vk_20190411_17
16.04.2019	Quidel Cardiovascular Inc.	Quidel Triage Drug Screen Control 1 Model: 94413 Lot: C3470AN	IVD: Multiple therapeutic drugs/drugs of abuse IVD, control	DE-1 FR-1 IT-1 EN-1	Vk_20190411_10
16.04.2019	Biomet Orthopaedics	T7 Driver AO Model: 110018531, 110018541 Lot: All Lots	MD: Surgical screwdriver, reusable	DE-1 FR-1 IT-1 EN-1	Vk_20190410_16
16.04.2019	Berchtold GmbH & Co. KG	Light Head Cover, Printed, F 528 / F628 Model: 83282, 83283 S/N: See FSN	MD: Lights, Surgical	DE-1 FR-1 IT-1 EN-1	Vk_20190410_09
16.04.2019	Abbott	Alinity i Processing Module Model: 03R65-01 S/N: All	IVD: Chemiluminescent immunoassay analyser IVD, automated	DE-1 FR-1 EN-1	Vk_20190409_21
16.04.2019	Medos International SARL	Concorde Lift Model: 197809221C, 197809226C, 197811221C, 197811226C, 197809223L, 197809227L, 197811223L, 197811227L Lot: All lots	MD: Metallic spinal fusion cage, sterile	DE-1 IT-1 EN-1	Vk_20190408_06
09.04.2019 (Updated16.04.2019)	Getinge - Maquet GmbH	MEERA with and w/o Drive Unit Model: 720001B2, 720001B0, 720001F2, 720001F0, 710001B2, 710001B0, 710001F0 S/N: 720001B2: SN 1 - SN 416, 720001B0: SN 1 - SN 1416, 720001F2: SN 1 - SN 91, 720001F0: SN 1 - SN 220, 710001B2: SN 1 - SN 8, 710001B0: SN 1 - SN 11, 710001F0: SN 1	MD: Universal operating table, electrohydraulic	DE-1 FR-1 EN-1	Vk_20190402_09
15.04.2019	BD Switzerland Sàrl	MaxZero Needleless Connector Model: MZ1000, MZ1000-07, MZ1000 CHINA, MZ5301, MZ5302, MZ5303, MZ5304, MZ5305, MZ5306, MZ5307, MZ5308, MZ5309, MZ5310, MZ5312, MZ5313, MZ5316, MZ8001, MZ8002, MZ8003, MZ9226, MZ9265, MZ9266, MZ9267, MZ9270, MZ9271, MZ9272, MZ9273, MZ9274, MZ9275, MZ9276, MZ9277 Lot: All	MD: Intravenous administration tubing extension set	DE-1 FR-1 EN-1	Vk_20190404_10
08.04.2019 (Updated15.04.2019)	Samsung Electronics Co., Ltd	GM85 Model: GM85 Lot: all S/N: all	MD: Mobile basic diagnostic x-ray system, digital	DE-1 FR-1 EN-1	Vk_20190402_12
15.04.2019	BIOSYNEX	Palutop +4 Optima Lot: all	IVD: Multiple Plasmodium species antigen IVD, kit, immunochromatographic test (ICT), rapid	FR-1.0 EN-1.0	Vk_20190318_08
12.04.2019	Zimmer Biomet GmbH	Alpha Durasul Inlay GG/32 Model: 01.00013.407 Lot: 2975251	MD: Non-constrained polyethylene acetabular liner	DE-1 FR-1 EN-1	Vk_20190412_10
12.04.2019	Mölnlycke Health Care AB	XRD swabs	MD: Neurosurgical procedure kit, non-medicated, single-use	DE-1	Vk_20190405_14
12.04.2019	BEKA Hospitec GmbH	Alu CARLO Classic Model: 924002000	MD: Mobile patient lifting system, battery-powered	DE-1 FR-1 IT-1 EN-1	Vk_20190405_11
04.04.2019 (Updated12.04.2019)	Stryker GmbH	TACTYS - IPP Prosthesis -Proximal Surface Model: Size L WIPSP11; Size M WIPSP10 Lot: Y23259 (Size L); Y23263 (Size M)	MD: Proximal interphalangeal joint prosthesis, modular	DE-1 FR-1 IT-1 EN-1	Vk_20190403_01
11.04.2019	EKOS Corporation inc.	EKOS Control System 4.0 - Connector interface cabl Model: 700-10410 Lot: 180918052; 181116028 S/N: 180918052-012; 181116028-003; 181116028-005; 181116028-006; 181116028-007; 181116028-014; 181116028-016; 181116028-019	MD: Ultrasound thrombolysis system control unit	DE-1 EN-1	Vk_20190405_08
11.04.2019	Invacare Deutschland GmbH	BORA, DRAGON, MIRAGE, SPECTRA BLITZ, STREAM S/N: 626 Dynamic Controls' Shark Power Modules with SN range: A18217618 - H18199840	MD: Wheelchairs, Powered	DE-1 EN-1	Vk_20190401_24
02.04.2019 (Updated11.04.2019)	Fresenius Medical Care AG & Co. KGaA	Granumix plus Model: F00003333 DIAMIX Model: 8002571, 8001571, 8004571, 8003571, 8006571, 8005571, 8008571, 8009571, F00001840, F00004888, F00003372, F00003384, F00003386	MD: Haemodialysis system fluid mixer MD: Haemodialysis concentrate	DE-2 FR-2 IT-2 EN-1	Vk_20190329_03
31.10.2018 (Updated11.04.2019)	Iris Diagnostics, a Division of Iris International	iChem VELOCITY Urine Chemistry Strips Model: 800-7212, 800-7204 Lot: see FSN	IVD: Urine rapid test device, multiple-constituent	DE-1 DE-2 FR-1 FR-2 EN-1 EN-2	Vk_20181024_11
10.04.2019	ASSAmed GmbH	Sauerstoffkatheter CH 10 Model: SKKS.10 Lot: 226.808	MD: Catheters, Nasal, Oxygen Supply	DE-1	Vk_20190408_15
10.04.2019	Dornier MedTech GmbH	Dornier Stadard Diode Nd:YAG Lightguides	MD: laser fibers MD: laser fibers	DE-1 EN-1	Vk_20190405_15
10.04.2019	Weinmann Emergency Medical Technology GmbH + Co.KG	Medumat Transport Model: WM 28415, WM 28315 MEDUMAT Standard Model: WM 22510, WM 22810 MODUL Oxygen Model: WM 22175 MODUL Combi Model: WM 22177 ULMER KOFFER Model: WM 8715, WM 8635, WM 3693, WM 5225	MD: Transport electric ventilator MD: Transport electric ventilator MD: Transport electric ventilator MD: Transport electric ventilator MD: Transport electric ventilator	DE-1 EN-1	Vk_20190404_17
10.04.2019 (Updated10.04.2019)	Siemens Healthcare GmbH	Cios Alpha Model: Cios Alpha VA20 Systems	MD: Portable general-purpose fluoroscopic x-ray system, digital	DE-1 FR-1 EN-1	Vk_20190328_04
02.04.2019 (Updated09.04.2019)	Abbott - Thoratec Corporation	HeartMate3 Outflow Graft, HeartMate3 LVAS Kit Model: 105581INT, 106524INT LVAS Kit	AIMD: Implantable ventricular circulatory assist system	DE-1 FR-1 IT-1 EN-1	Vk_20190402_01
03.04.2019 (Updated09.04.2019)	Edwards Lifesciences LLC	Vamp Optima Model: MHD8VLTW, MHD8VRL5 and VOPTIMAL Lot: All lots for models listed.	MD: Arterial blood sampling kit	DE-1 FR-1 EN-1	Vk_20190329_13
02.04.2019 (Updated09.04.2019)	Nobel Biocare AB	Single-patient use drills for NobelReplace, Guided Start Drills/Counterbores and Guided Counterbores for NobelReplace, Implant Retrieval Instruments, Abutment Screw Retrieval Instruments Model: see fsn Lot: see fsn	MD: Fixture/appliance dental drill bit, Bone tap, Dental implant extractor, Screw extractor, Dental implant/prosthesis surgical procedure kit	DE-1 FR-1 IT-1 EN-1	Vk_20190328_01
01.04.2019 (Updated08.04.2019)	Zimmer GmbH	Foot and Ankle Inst. (Drill / Tap and Countersink) Model: See FSN, Annex 2 Lot: All batches manufactured by Normed Medizin Technik	MD: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile	DE-1_dist DE-1_user DE-2_dist DE-2_user FR-1_dist FR-1_user FR-2_dist FR-2_user IT-1_dist IT-1_user IT-2_dist IT-2_user EN-1_dist EN-1_user	Vk_20190328_14
08.04.2019	Biotronik AG	Cruiser Model: 351461 & 351468 Lot: 06183710 & 06182718 S/N: - SW-Version: -	MD: Cardiac/peripheral vascular guidewire, single-use	EN-1	Vk_20190327_08
28.03.2019 (Updated08.04.2019)	DiaMed GmbH	IH-Com Kit Fullversion Model: 009000 SW-Version: All versions IH-Com Kit For Reader Model: 009010 SW-Version: All versions	IVD: Laboratory instrument/analyser application software IVD IVD: Laboratory instrument/analyser application software IVD	DE-1 EN-1	Vk_20190322_03
02.04.2019 (Updated05.04.2019)	Mölnlycke Health Care AB	Mölnlycke Detachable EndoRetrieval Pouch Model: 899103-01 Lot: 6251809030	MD: Tissue extraction bag	DE-1 FR-1 EN-1	Vk_20190329_08
04.04.2019	Thommen Medical AG	Adapter for handpiece, guided reusable, for guide Model: 3.04.090 Lot: 17415	MD: Surgical screwdriver, reusable	DE-1_distributor DE-1_enduser EN-1_distributor	Vk_20190328_11
20.03.2019 (Updated04.04.2019)	Leica Biosystems Nussloch GmbH	Leica Biosystems Cryostats Model: see FSN S/N: see FSN	IVD: Cryostat microtome	DE-1 FR-1 IT-1 EN-1	Vk_20190318_11
03.04.2019	GE Medical Systems Israel, Functional Imaging	Discovery NM 630, Discovery NM/CT 670 CZT, Discovery NM/CT 670 DR, Discovery NM/CT 670 ES, Optima NM/CT 640, NM 830, NM/CT 850, NM/CT 860, NM/CT 870 CZT, NM/CT 870 DR	MD: Stationary gamma camera system	DE-1 FR-1 IT-1 EN-1	Vk_20190327_16
27.03.2019 (Updated03.04.2019)	Synthes GmbH	Femoral Neck System Insert for Insertion Handle Model: 03.168.009 Lot: 170009-102, 170009-103, 170009-104, 170009-105, 170330-101, 170330-102, 170330-103	MD: Orthopaedic implantation sleeve, reusable	DE-1 IT-1 EN-1	Vk_20190326_13
28.03.2019 (Updated03.04.2019)	Fresenius Kabi AG	CompoStop Systeme Model: PD51600, PT52600 Lot: See FSN	MD: Blood donor set, double-pack, Blood donor set, triple-pack	DE-1 FR-1 IT-1 EN-1	Vk_20190325_38
02.04.2019	Datex-Ohmeda, Inc (GE Healthcare)	Aisys CS2 SW-Version: 11SP01, 11SP02 Aisys SW-Version: 11SP01, 11SP02	MD: Anaesthesia workstation, general-purpose MD: Anaesthesia workstation, general-purpose	DE-1 FR-1 IT-1 EN-1	Vk_20190401_30
02.04.2019	Dräger Medical AG & Co.	Breathing circuits VentStar Helix Model: See attached FSN with material number list	MD: Tubing	DE-1 EN-1	Vk_20190401_28
02.04.2019	A.R.C. Laser GmbH	Wolf mit der Wellenlänge 445nm SW-Version: Chip combination V1.3	MD: Lasers	DE-1	Vk_20190401_26
02.04.2019	Datex-Ohmeda, Inc	Panda iRes Warmer S/N: See FSN Giraffe Warmer S/N: See FSN	MD: Infant warmer MD: Infant warmer	DE-1 FR-1 IT-1	Vk_20190401_22
02.04.2019	ViewRay Inc.	MRIdian Linac System Model: 20000	MD: Stereotactic teletherapy radionuclide system, MRI-imaging	DE-1 FR-1 IT-1 EN-1	Vk_20190328_03
02.04.2019	Brainlab AG	RT Elements Model: Cranial SRS 1.0.0/1.5.0; Spine SRS 1.0.0/1.5.0; Multiple Brain Mets; SRS 1.5.0; RT QA 1.0.0/1.5.0 Lot: N/A S/N: N/A	MD: Radiation therapy software	DE-1 FR-1 IT-1 EN-1	Vk_20190326_09
02.04.2019	Hoggi GmbH	CLEO Model: 3279-0028 S/N: 201849983, 201849911, 201850901, 201851893, 201850755. 201851914, 201853689, 201853690, 201854605	MD: Wheelchairs	DE-1 EN-1	Vk_20190322_07