Швейцарія
https://fsca.swissmedic.ch/mep/#/
18.09.2018 (Updated02.10.2018) |
CooperSurgical Inc. |
Lone Star Single-Use Elastic Stays |
MD: Laparoscopic access cannula, single-use |
Vk_20180917_02 |
|
11.09.2018 (Updated02.10.2018) |
Bio-Rad France |
Pastorex Meningitis |
IVD: Multiple meningitis-associated bacteria antigen IVD, kit, agglutination |
Vk_20180905_16 |
|
26.09.2018 (Updated28.09.2018) |
Abbott |
Alinity i Processing Module |
IVD: Chemiluminescent immunoassay analyser IVD, automated |
Vk_20180919_03 |
|
27.09.2018 |
Siemens AG Medizinische Technik - AX |
ARTIS pheno systems |
MD: Stationary angiographic x-ray system, digital |
Vk_20180925_04 |
|
27.09.2018 (Updated27.09.2018) |
CooperSurgical Inc. |
Colpo-Pneumo Occluder |
MD: Laparoscopic access cannula, single-use |
Vk_20180924_03 |
|
21.09.2018 (Updated27.09.2018) |
Teleflex Medical SND BHD |
CrystalClear Plus, RUSCH CARE CrystalClear (PVC) Tracheostomy Cannula (no Cuff) - Set, RUSCH CrystalClear (PVC) Tracheostomy Cannula (Cuffed / no Cuff) |
MD: Basic tracheostomy tube, single-use |
Vk_20180921_08 |
|
26.09.2018 |
Inpeco S.A. |
Aptio Automation |
IVD: Specimen processing instrument IVD, automated |
Vk_20180924_09 |
|
25.09.2018 (Updated26.09.2018) |
Medtronic Navigation Inc. |
O-arm 1000 Surgical Imaging System (2nd edition) |
MD: Portable general-purpose fluoroscopic x-ray system, digital |
Vk_20180920_12 |
|
18.09.2018 (Updated26.09.2018) |
Cardiac Pacemaker Inc |
ACCOLADE ESSENTIO MRI VISIONIST X4 VALITUDE X4 ACCOLADE MRI PROPONENT PROPONENT MRI ESSENTIO |
AIMD: Single/Dual Chamber Pacemakers (rate responsive) AIMD: Single/Dual Chamber Pacemakers (rate responsive) AIMD: Cardiac resynchronization therapy implantable pacemaker AIMD: Cardiac resynchronization therapy implantable pacemaker AIMD: Single/Dual Chamber Pacemakers (rate responsive) AIMD: Single/Dual Chamber Pacemakers (rate responsive) AIMD: Single/Dual Chamber Pacemakers (rate responsive) AIMD: Single/Dual Chamber Pacemakers (rate responsive) |
Vk_20180911_13 |
|
25.09.2018 |
Beckman Coulter, Inc. |
Kaluza C Software |
IVD: Laboratory instrument/analyser application software IVD |
Vk_20180921_10 |
|
25.09.2018 |
Carl Zeiss Microscopy GmbH |
Cell Observer SD / Laser TIRF / DirectFRAP |
IVD: Microscope, scanning laser optical |
Vk_20180919_16 |
|
25.09.2018 |
Endologix International Holdings B.V. |
AFX EndoVascular AAA System |
MD: Abdominal aorta endovascular stent-graft |
Vk_20180919_10 |
|
25.09.2018 |
Bayer Medical Care Inc. |
Low Volume IV Filter |
MD: filters used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems |
Vk_20180919_01 |
|
25.09.2018 |
Siemens Healthcare Diagnostics Inc. |
Dimension Lipase |
IVD: Lipase IVD, kit, enzyme spectrophotometry |
Vk_20180918_10 |
|
25.09.2018 |
Data Innovations LLC |
Instrument Manager Software |
IVD: INSTRUMENTS , CONSUMABLES, SPARE PARTS, SOFTWARE, SERVICE |
Vk_20180918_08 |
|
20.09.2018 (Updated24.09.2018) |
GE Medical Systems Israel, Functional Imaging |
Millennium MG, Millennium MC, Millennium MYOSIG |
MD: Stationary gamma camera system |
Vk_20180919_23 |
|
28.08.2018 (Updated24.09.2018) |
Inpeco S.A. |
Aptio Automation |
IVD: Specimen processing instrument IVD, automated |
Vk_20180828_09 |
|
28.08.2018 (Updated24.09.2018) |
Inpeco S.A. |
ACCELERATOR a3600 |
IVD: Specimen processing instrument IVD, automated |
Vk_20180828_08 |
|
28.08.2018 (Updated24.09.2018) |
Inpeco S.A. |
FlexLab |
IVD: Specimen processing instrument IVD, automated |
Vk_20180828_03 |
|
21.09.2018 |
Axis-Shield Diagnostics Limited |
Alere NT-proBNP for ARCHITECT Controls |
IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control |
Vk_20180914_11 |
|
29.08.2018 (Updated21.09.2018) |
Hitachi High Technologies Corporation (HHT) |
cobas e 411 |
IVD: Chemiluminescent immunoassay analyser IVD, automated |
Vk_20180827_02 |
|
28.08.2018 (Updated21.09.2018) |
Sysmex Corporation |
Automated Hematology Analyzer XN series |
IVD: Haematology analyser |
Vk_20180824_02 |
|
04.09.2018 (Updated20.09.2018) |
HeartWare Inc. |
HeartWare Ventricular Assist System |
AIMD: Implantable ventricular circulatory assist system |
Vk_20180831_02 |
|
19.09.2018 |
Varian Medical Systems Inc. |
TrueBeam TrueBeam STx VitalBeam EDGE |
MD: Linear accelerator system MD: Linear accelerator system MD: Linear accelerator system MD: Linear accelerator system |
Vk_20180914_13 |
|
19.09.2018 |
Dispomedica |
Embolectomy Catheters |
MD: Catheters, Vascular, Embolectomy/Thrombectomy |
Vk_20180914_07 |
|
19.09.2018 |
BIOLABO |
CHOLESTEROL-HDL Direct Method 200-250 TESTS CHOLESTEROL-HDL Direct Method 400-500 TESTS CHOLESTEROL-LDL Direct Method 100 - 125 TESTS CHOLESTEROL-HDL Direct Method 2000-2500 TESTS CHOLESTEROL-LDL Direct Method 200 - 250 TESTS HDL LDL CK-MB CALIBRATOR HDL LDL CK-MB Lipids Level 1 Control Serum HDL LDL CK-MB Lipids Level 2 Control Serum |
IVD: IVD: IVD: IVD: IVD: IVD: IVD: IVD: |
Vk_20180905_21 |
|
18.09.2018 |
Siemens Healthcare Diagnostics Inc. |
ADVIA Chemistry Creatine Kinase Assay |
IVD: Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry |
Vk_20180917_08 |
|
18.09.2018 |
Alere Toxicology Plc |
Alere DDS2 Test Kit |
: Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid |
Vk_20180913_11 |
|
18.09.2018 |
Cardiac Pacemaker Inc |
LATITUDE Programmer |
AIMD: Cardiac pulse generator programmer |
Vk_20180911_14 |
|
11.09.2018 (Updated17.09.2018) |
Greggersen Gasetechnik GmbH |
Vakuumregler Pirol |
MD: Regulator, suction |
Vk_20180907_02 |
|
17.09.2018 |
icotec ag |
Cannulated tap, 5.5 mm |
MD: Bone tap, reusable |
Vk_20180906_09 |
|
17.09.2018 |
Therakos Inc. |
Cellex Photopheresis System |
MD: Photopheresis system |
Vk_20180905_09 |
|
17.09.2018 |
Implant Direct Sybron Manufacturing LLC |
RePlant Precision IO Scan Adapter |
MD: Dental guided surgery reference pin |
Vk_20180904_09 |
|
29.08.2018 (Updated17.09.2018) |
Covidien LLC |
Covidien EEA Circular Stapler w. Tri-Staple Techn. |
MD: Intraluminal circular stapler, single-use |
Vk_20180828_05 |
|
12.09.2018 |
RECIPE Chemicals + Instruments GmbH |
ClinRep® Complete Kit for Antiepileptics in Serum / Plasma with UHPLC |
IVD: Other Other Clinical Chemistry Reagents |
Vk_20180910_08 |
|
12.09.2018 |
I2A - Intelligence Artificielle Applications SA |
SIRscan discs Amoxicillin 2 ¿g + clavulanic acid 1 ¿g |
IVD: IVD Test Reagent/Kits, Cytology/Histology, Decalcifying, Light Microscopy |
Vk_20180905_19 |
|
12.09.2018 |
Sysmex Corporation |
Automated Hematology Analyser XN-Series |
IVD: Haematology analyser |
Vk_20180905_18 |
|
11.09.2018 |
Hitachi High Technologies Corporation (HHT) |
cobas e 411 |
IVD: Chemiluminescent immunoassay analyser IVD, automated |
Vk_20180911_02 |
|
11.09.2018 (Updated11.09.2018) |
Cordis Corporation |
POWERFLEX PRO PTA Dilatation Catheter |
MD: Peripheral angioplasty balloon catheter, basic |
Vk_20180910_12 |
|
11.09.2018 |
Arthrex INC |
DrillSaw Sports 400 System Li-Ion Battery Housing |
MD: Surgical power tool system handpiece, sawing, rechargeable battery-powered |
Vk_20180907_09 |
|
11.09.2018 |
Thoratec Switzerland GmbH |
CentriMag Motor |
MD: Cardiopulmonary bypass system centrifugal pump drive unit |
Vk_20180906_01 |
|
11.09.2018 |
Beckman Coulter, Inc. |
Lipase Uric Acid |
IVD: Lipase IVD, kit, enzyme spectrophotometry IVD: Uric acid IVD, kit, enzyme spectrophotometry |
Vk_20180905_24 |
|
11.09.2018 |
Alere San Diego, Inc |
Alere Triage NT-proBNP Test |
IVD: BNP / proBNP (including other Natriuric Peptides) |
Vk_20180903_15 |
|
10.09.2018 |
Ovesco Endoscopy |
AWC-Additional Working Channel |
MD: Endoscope channel support kit |
Vk_20180903_14 |
|
03.09.2018 (Updated10.09.2018) |
Roche Diagnostics GmbH |
cobas h 232 CoaguChek XS CoaguChek XS Pro CoaguChek XS Plus CoaguChek Pro II Accu-Chek Inform II |
IVD: Enzyme immunoassay (EIA) analyser IVD, semi-automated IVD: Coagulation analyser IVD, laboratory, semi-automated IVD: Coagulation analyser IVD, laboratory, semi-automated IVD: Coagulation analyser IVD, laboratory, semi-automated IVD: Coagulation analyser IVD, laboratory, semi-automated IVD: Glucose analyser IVD, point-of-care |
Vk_20180828_01 |
|
09.09.2018 |
B. Braun Melsungen AG |
INTRAFIX SAFESET LL |
MD: Electric infusion pump administration set, single-use |
Vk_20180903_05 |
|
29.08.2018 (Updated09.09.2018) |
Degania Silicone Ltd. |
Mon-a-Therm Foley catheters with temperature sensors |
MD: Temperature-monitoring indwelling urethral drainage catheter |
Vk_20180827_07 |
|
07.09.2018 |
Haemonetics S.A. |
Plasma collection HS bowl |
MD: Apheresis system tubing set |
Vk_20180831_18 |
|
20.07.2018 (Updated07.09.2018) |
ConvaTec Limited |
Suction Catheters Intermittent Urology Catheters Sterile Urine Drainage Bags Gastro-enteral Tubes |
MD: Tracheal suction catheter MD: Single-administration urethral drainage catheter MD: Open-ended non-wearable urine collection bag, sterile MD: Duodenal Tubes, Stomach Tubes and Feeding Tubes |
DE-1 |
Vk_20180709_08 |
04.09.2018 |
BioFire Diagnostics, LLC |
FilmArray Blood Culture Identification Panel-BCID |
IVD: Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry |
Vk_20180903_11 |
|
11.07.2018 (Updated04.09.2018) |
SEDECAL S.A. |
Nova |
MD: X-ray system tube support, ceiling mount |
Vk_20180709_02 |
|
04.09.2018 |
Siemens Healthcare Diagnostics Inc. |
Syva Emit II Plus 6-Acetylmorphine assay |
IVD: Unclassified |
Vk_20180326_03 |
|
03.09.2018 |
Alcon Laboratories, Inc. |
CyPass Micro-Stent |
MD: Glaucoma shunt |
Vk_20180829_16 |
|
31.08.2018 |
Biocartis NV |
Idylla Instrument |
: Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated |
Vk_20180821_04 |
|
20.08.2018 (Updated31.08.2018) |
Vision RT Limited |
AlignRT |
MD: Video camera patient positioning/tracking system |
Vk_20180813_12 |
|
28.08.2018 (Updated30.08.2018) |
William Cook Europe ApS |
Zenith Alpha Thoracic Endovascular Graft |
MD: Synthetic vascular graft |
Vk_20180821_07 |
|
30.08.2018 |
MEDOS Medizintechnik AG |
s.pump |
MD: Cardiopulmonary bypass system centrifugal pump |
Vk_20180821_05 |
|
21.08.2018 (Updated30.08.2018) |
Oridion Medical 1987 Ltd. |
Capnostream 20 and Capnostream 20p Bedside Patient Monitors |
MD: Carbon dioxide monitor |
Vk_20180816_08 |
|
30.08.2018 |
Siemens Healthcare GmbH, Diagnostic Imaging, X-Ray-Products |
Ysio Ysio Max |
MD: Stationary basic diagnostic x-ray system, digital MD: Stationary basic diagnostic x-ray system, digital |
Vk_20180814_06 |
|
30.08.2018 |
BD Switzerland Sàrl |
Alaris / Asena CC, GH Syringe Pump |
MD: Syringe pump |
Vk_20180803_17 |
|
29.08.2018 |
Maquet Critical Care AB |
Servo-n |
MD: Neonatal/adult intensive-care ventilator |
Vk_20180828_02 |
|
27.08.2018 (Updated29.08.2018) |
Leica Microsystems (Schweiz) AG |
Leica M525 F20 |
MD: General-purpose surgical microscope |
Vk_20180820_04 |
|
28.08.2018 |
Siemens Healthcare Diagnostics Inc. |
Aptio Automation System/StreamLAB Analytical Workcell |
IVD: Specimen processing instrument IVD, automated |
Vk_20180827_05 |
|
28.08.2018 |
Siemens Medical Solutions USA, Inc. |
Biograph mCT systems, Biograph mCT Flow systems |
MD: Stationary gamma camera system |
Vk_20180824_01 |
|
28.08.2018 |
Roche Diagnostics GmbH |
CoaguChek PT Test |
IVD: Prothrombin time (PT) IVD, kit, clotting, rapid |
Vk_20180822_14 |
|
28.08.2018 |
MetaSystems Probes GmbH |
XL t(3;3) GATA2/MECOM DF |
IVD: Acquired genetic alteration IVDs |
Vk_20180822_12 |
|
28.08.2018 |
Valtech Cardio Ltd. |
Cardioband Mitral Reconstruction System |
MD: Mitral annuloplasty ring |
Vk_20180821_03 |
|
27.08.2018 |
ACUTRONIC Medical Systems AG |
fabian Therapy evolution |
MD: Neonatal intensive-care ventilator |
Vk_20180816_02 |
|
27.08.2018 |
CIVCO Medical Instruments CO |
Endocavity Needle Guide |
MD: Nonimplantable needle guide, single-use |
Vk_20180816_01 |
|
27.08.2018 |
Peek Vision Ltd |
Peek Acuity Pro App |
MD: Dynamic visual acuity testing system |
Vk_20180814_21 |
|
15.08.2018 (Updated27.08.2018) |
BioGX BV |
BioGX |
IVD: Unclassified |
Vk_20180814_01 |
|
14.08.2018 (Updated27.08.2018) |
Ventana Medical Systems Inc |
FLO-LOK III Dispenser |
IVD: Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry |
Vk_20180809_03 |
|
14.08.2018 (Updated27.08.2018) |
Medica, Medizintechnik GmbH |
THERA-Trainer balo / THERA-Trainer verto |
MD: Exerciser |
Vk_20180807_04 |
|
14.08.2018 (Updated27.08.2018) |
Esaote S.p.a. |
MyLab |
MD: General-purpose ultrasound imaging system |
Vk_20180802_21 |
|
27.08.2018 |
Intuitive Surgical, Inc |
da Vinci EndoWrist Monopolar Curved Scissors |
MD: Robotic electrosurgical instrument, monopolar, reusable |
Vk_20180731_01 |
|
22.08.2018 (Updated23.08.2018) |
BioMérieux Inc. |
AST-P640 Test Kit and AST-P655 Test Kit |
IVD: General-microorganism antimicrobial susceptibility culture medium IVD |
Vk_20180816_13 |
|
22.08.2018 (Updated23.08.2018) |
Siemens Healthcare Diagnostics Inc. |
Hematek Wright-Giemsa Stain Pak Hematek Modified Wright Stain Pak |
IVD: Wright-Giemsa staining solution IVD IVD: Wright staining solution IVD |
Vk_20180814_16 |
|
22.08.2018 (Updated23.08.2018) |
Siemens Healthcare GmbH |
Artis Q ARTIS pheno systems |
MD: Stationary angiographic x-ray system, digital MD: Stationary angiographic x-ray system, digital |
Vk_20180814_08 |
|
22.08.2018 |
Chalybs Medical Devices GmbH |
Knopfkanüle gebogen |
MD: Cannula |
Vk_20180822_15 |
|
22.08.2018 |
Ortho Clinical Diagnostics Inc. |
VITROS 5600 |
IVD: Clinical chemistry analyser |
Vk_20180817_01 |
|
21.08.2018 |
Dr. Mach GmbH & Co. GmbH |
Lighting systems consisting of flange tubes and lights from Dr. Mach and the associated suspension system (heavy central axis, extension arm and spring arm) from the suspension system manufacturer. |
MD: Operating shadowless light |
Vk_20180807_02 |
|
15.08.2018 (Updated20.08.2018) |
Philips Medical Systems Nederland BV |
Allura Xper and Integris |
MD: Stationary general-purpose fluoroscopic x-ray system, analogue |
Vk_20180813_01 |
|
20.08.2018 |
Frei AG - Aktive Rehasysteme |
Gym Treatment Table Gym X Treatment Table |
MD: Physical therapy table, non-powered MD: Tables, Examination/Treatment, Adjustable, Physical Therapy |
Vk_20180809_07 |
|
20.08.2018 |
Infomed SA |
Plasmafractionator Medopen |
MD: |
Vk_20180809_05 |
|
20.08.2018 |
Medtronic MiniMed |
MiniMed remote controller |
MD: Basic remote control |
Vk_20180808_11 |
|
15.08.2018 |
Agfa Healthcare |
DX-D 600 |
MD: Stationary basic diagnostic x-ray system, digital |
Vk_20180809_06 |
|
14.08.2018 |
SOMATEX Medical Technologies GmbH |
Transplant-Aspiration Needle Biopsy Cannula SPI-CUT |
MD: Biopsy needle, general-purpose, single-use MD: Biopsy needle, general-purpose, single-use |
Vk_20180810_03 |
|
14.08.2018 |
Medcomp |
Double Lumen Catheter Set |
MD: Double-lumen haemodialysis catheter, nonimplantable |
Vk_20180719_01 |
|
13.08.2018 |
Datex Ohmeda; GE Medical Systems (China) Co., Ltd |
Carestation 620, Carestation 650, Carestation 650c Carestation 30, 9100c NXT |
MD: Anaesthesia workstation, general-purpose MD: Anaesthesia workstation, general-purpose |
Vk_20180808_01 |
|
13.08.2018 |
Beckman Coulter, Inc. |
UniCel DxH 600 Coulter Cellular Analysis System UniCel DxH 800 Coulter Cellular Analysis System |
IVD: Haematological cell analyser IVD, automated IVD: Haematological cell analyser IVD, automated |
Vk_20180802_25 |
|
08.08.2018 (Updated13.08.2018) |
Philips Medical Systems |
Philips SureSigns VS & VM Monitors, and View Station (VSV) |
MD: Single-patient physiologic monitoring system |
Vk_20180802_23 |
|
26.07.2018 (Updated13.08.2018) |
AURUM HEALTHCARE |
Aurum Healthcare Tubing Systems |
MD: Non active devices for anesthesia, emergency and intensive care; non active devices for injection, infusion, transfusion and dialysis |
Vk_20180717_12 |
|
03.07.2018 (Updated13.08.2018) |
RaySearch Laboratories AB |
RayStation |
MD: Radiation therapy software |
Vk_20180702_18 |
|
10.08.2018 |
Smiths Medical MD, Inc. |
Gripper Plus needle PORT-A-CATH Plastic Hub Bent Needle |
MD: Subcutaneous injection/infusion port needle MD: Subcutaneous injection/infusion port needle |
Vk_20180806_07 |
|
09.08.2018 (Updated09.08.2018) |
Siemens Healthcare Diagnostics Inc. |
ADVIA Centaur CKMB Calibrator Atellica IM CKMB Calibrator ADVIA Centaur CKMB MCM Atellica IM CKMB MCM |
IVD: Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator IVD: Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator IVD: Creatine kinase myocardial isoenzyme (CKMB) IVD, control IVD: Creatine kinase myocardial isoenzyme (CKMB) IVD, control |
Vk_20180802_12 |
|
08.08.2018 (Updated09.08.2018) |
EOS imaging |
sterEOS image review workstation |
MD: Radiology DICOM image processing application software |
Vk_20180802_03 |
|
02.08.2018 (Updated09.08.2018) |
Idoman Teoranta |
Thermablate EAS |
MD: Endometrial-ablation hyperthermia control unit |
Vk_20180725_12 |
|
15.05.2018 (Updated09.08.2018) |
Roche Diagnostics GmbH |
cobas m 511 integrated hematology analyzer |
IVD: Cell morphology analyser IVD, automated |
Vk_20180509_02 |
|
08.08.2018 |
Bausch & Lomb Inc. |
Stellaris Elite Single Port Vitrectomy Cutters |
MD: Ophthalmic surgical procedure kit, non-medicated, single-use |
Vk_20180806_06 |
|
07.08.2018 |
Covidien LLC |
BIS Vista and BIS View Monitoring Systems |
MD: Anaesthesia depth monitor |
Vk_20180806_09 |
|
07.08.2018 |
Biomet Orthopaedics, LLC |
Affixus Hip Fracture Nail |
MD: Femur nail, sterile |
Vk_20180802_24 |
|
07.08.2018 |
Weinmann Emergency Medical Technology GmbH + Co.KG |
MEDUMAT Transport Akkupack or Akkupack Plus |
MD: Transport electric ventilator |
Vk_20180724_07 |
|
03.08.2018 |
Reckitt Benckiser Healthcare (UK) Limited |
Durex Natural Feeling, Natural Feeling Easy Glide and Love Collection |
MD: Basic male condom, synthetic polymer |
DE-Grosshandelsrückruf |
Vk_20180726_08 |
02.08.2018 (Updated03.08.2018) |
Abbott |
ARCHITECT EBV VCA IgM |
IVD: Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay |
Vk_20180725_08 |
|
31.07.2018 (Updated02.08.2018) |
MAQUET Cardiopulmonary GmbH |
HCU40 |
MD: Cardiopulmonary bypass system heat exchanger |
Vk_20180731_02 |
|
31.07.2018 (Updated02.08.2018) |
Integra LifeSciences Corporation |
Knob Assembly contained in MAYFIELD |
MD: Knob assembly of the MAYFIELD Infinity XR2 Swivel Adapter (Skull Clamp) |
Vk_20180725_01 |
|
02.08.2018 |
Siemens Healthcare Diagnostics Inc. |
RAPIDPoint 405/500 Systems RAPIDLab 1245/1265 Systems |
IVD: Blood gas/pH/electrolyte/metabolite analyser IVD: Blood gas/pH/electrolyte/metabolite analyser |
Vk_20180724_08 |
|
23.07.2018 (Updated02.08.2018) |
Servona GmbH |
Servona Silberkanüle |
MD: Cannula, Tracheostomy, Reusable |
Vk_20180713_06 |
|
02.08.2018 |
Dako North America, Inc. |
Monoclonal Mouse Anti-Human MSH2 FE11 |
IVD: Streptococcus A rapid test device |
Vk_20180628_07 |
|
02.07.2018 (Updated02.08.2018) |
Frei AG - Aktive Rehasysteme |
Arcus - treatment table |
MD: Tables, Examination/Treatment, Adjustable, Physical Therapy |
Vk_20180622_06 |
|
31.07.2018 |
The Binding Site Group Limited |
Human IgM Kit for use on SPAPLUS |
IVD: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry |
Vk_20180727_03 |
|
31.07.2018 |
Qiagen GmbH |
EZ1 Advanced XL |
IVD: Other Other Genetic Tests |
Vk_20180725_02 |
|
24.07.2018 (Updated31.07.2018) |
EDAP TMS FRANCE |
Sonolith i-move |
MD: Lithotripsy system, external |
Vk_20180723_01 |
|
25.07.2018 (Updated31.07.2018) |
Diagnostica Stago |
STA Néoplastine CI 10 and CI Plus 10 |
IVD: Prothrombin time kit |
Vk_20180720_14 |
|
25.07.2018 (Updated31.07.2018) |
Mikrogen GmbH |
recomWell Borrelia IgM |
IVD: Lyme Antibody IgM |
Vk_20180718_01 |
|
25.04.2018 (Updated31.07.2018) |
Roche Diagnostics GmbH |
Vitamin D total II, Elecsys Vitamin D total II |
IVD: 25-Hydroxy vitamin D3 IVD, reagent |
Vk_20180418_01 |
|
25.07.2018 (Updated30.07.2018) |
Cepheid AB |
Xpert C.Difficile BT |
IVD: Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT) |
Vk_20180723_09 |
|
24.07.2018 (Updated30.07.2018) |
Ortho Clinical Diagnostics |
VITROS Immunodiagnostic Products Folate Reagent Pack VITROS Immunodiagnostic Products Free PSA Reagent Pack VITROS Immunodiagnostic Products FSH Reagent Pack VITROS Immunodiagnostic Products Prolactin Reagent Pack VITROS Immunodiagnostic Products TSH Reagent Pack |
IVD: Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay IVD: Free (unbound) prostate specific antigen (PSA) IVD, kit, chemiluminescent immunoassay IVD: Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay IVD: Prolactin IVD, kit, chemiluminescent immunoassay IVD: Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay |
Vk_20180723_08 |
|
25.07.2018 (Updated30.07.2018) |
Abbott |
Alinity c Creatine Kinase |
IVD: Total creatine kinase (CK) IVD, reagent |
Vk_20180720_03 |
|
25.07.2018 (Updated30.07.2018) |
Abbott Laboratories |
ARCHITECT Creatine Kinase |
IVD: Total creatine kinase (CK) IVD, reagent |
Vk_20180720_02 |
|
25.07.2018 (Updated30.07.2018) |
Abbott Laboratories |
ARCHITECT c4000 / c8000 / c16000 Processing Module |
IVD: Multichannel clinical chemistry analyser IVD, laboratory, automated |
Vk_20180718_12 |
|
30.07.2018 |
B. Braun Melsungen AG |
Perifix Catheter Connector |
MD: Luer adaptor |
Vk_20180716_11 |
|
26.07.2018 (Updated27.07.2018) |
Regen Lab SA |
ArthroVisc40 Cellular Matrix SkinVisc40 |
MD: Synovial fluid supplementation medium MD: Haematological concentrate system kit, platelet concentration MD: Dermal tissue reconstructive material, microbe-derived |
Vk_20180716_04 |
|
26.06.2018 (Updated27.07.2018) |
Stryker Trauma Kiel |
T2 Ankle Arthrodesis Nail, left T2 Ankle Arthrodesis Nail, right T2 Proximal Humeral Nail, left T2 Proximal Humeral Nail, right |
MD: Arthrodesis nail, sterile MD: Arthrodesis nail, sterile MD: Humerus nail, sterile MD: Humerus nail, sterile |
Vk_20180618_02 |
|
05.12.2016 (Updated27.07.2018) |
Siemens Healthcare Diagnostics Products Limited |
IMMULITE 1000 PSA IMMULITE 2000 Xpi PSA IMMULITE PSA IMMULITE 2000 PSA |
IVD: Prostate specific antigen kit IVD: Total prostate specific antigen (PSA) IVD, kit, chemiluminescent immunoassay IVD: Prostate specific antigen kit IVD: Total prostate specific antigen (PSA) IVD, kit, chemiluminescent immunoassay |
Vk_20161128_12 |
|
20.07.2018 (Updated26.07.2018) |
Medtronic Inc. |
Vectris Lead Kits |
AIMD: Neural-tissue electrical stimulation lead |
Vk_20180716_09 |
|
26.07.2018 |
William A. Cook Australia Pty Ltd |
Zenith Branch Endovascular Graft Iliac Bifurcation |
MD: Synthetic vascular graft |
Vk_20180226_08 |
|
25.07.2018 |
Steris Corporation |
AMSCO V-PRO 1 V-PRO 1 Plus VPRO maX |
MD: Hydrogen peroxide gas sterilizer MD: Hydrogen peroxide gas sterilizer MD: Hydrogen peroxide gas sterilizer |
Vk_20180720_12 |
|
25.07.2018 |
Medline International France SAS |
LDH SET, NEURO OPS AUGEN-SET SRRWS CRANIOTOMIE SET,NEURO OPS |
MD: General/plastic surgical procedure kit, non-medicated, single-use MD: General/plastic surgical procedure kit, non-medicated, single-use MD: General/plastic surgical procedure kit, non-medicated, single-use |
Vk_20180719_15 |
|
25.07.2018 |
Horiba ABX SAS |
Yumizen H2500 & H2500 SPS |
IVD: Haematology analyser, cell differential |
Vk_20180719_12 |
|
17.07.2018 (Updated25.07.2018) |
Cerus Corporation |
INTERCEPT Processing Set for LV Platelet Units |
MD: Platelet photochemical treatment kit |
Vk_20180716_16 |
|
19.06.2018 (Updated25.07.2018) |
RaySearch Laboratories AB |
RayStation |
MD: Radiation therapy software |
Vk_20180608_06 |
|
24.07.2018 |
Gebr. Gloor AG |
SWISS optio terminal unit AGSS |
MD: Medical Gas Outlets |
Vk_20180720_21 |
|
24.07.2018 |
Siemens Healthcare GmbH; Business Area Advanced Therapies |
Artis Q/Pheno systems |
MD: Stationary angiographic x-ray system, digital |
Vk_20180719_19 |
|
28.06.2018 (Updated23.07.2018) |
Radiometer Medical ApS |
ABL800 |
IVD: Metabolic profile clinical chemistry analyser IVD, stationary, automated |
Vk_20180620_03 |
|
26.06.2018 (Updated23.07.2018) |
Microgenics Corporation |
QMS Teicoplanin |
IVD: Teicoplanine kit |
Vk_20180619_12 |
|
14.11.2017 (Updated23.07.2018) |
MULLIEZ FLORY |
SECURIDRAP SELFIA |
MD: safety bedding |
Vk_20170728_06 |
|
17.07.2018 (Updated20.07.2018) |
bioMérieux SA |
VIDAS CA 15-3 |
IVD: Cancer antigen 15-3 kit |
Vk_20180716_06 |
|
20.07.2018 |
DiaMed GmbH |
IH-Com Kit Fullversion IH-Com Kit For Reader |
IVD: Laboratory instrument/analyser application software IVD IVD: Laboratory instrument/analyser application software IVD |
Vk_20180710_11 |
|
19.07.2018 |
William A. Cook Australia Pty Ltd |
Cook Chorionic Villus Biopsy Needle Set |
MD: Biopsy needle, general-purpose, single-use |
Vk_20180717_05 |
|
17.07.2018 (Updated19.07.2018) |
BEKA Hospitec GmbH |
Alu CARLO |
MD: Mobile patient lifting system, battery-powered |
Vk_20180710_02 |
|
19.07.2018 |
Frei AG - Aktive Rehasysteme |
Height-adjustable training table |
MD: Tables, Examination/Treatment, Adjustable, Physical Therapy |
Vk_20180709_09 |
|
04.07.2018 (Updated19.07.2018) |
Fresenius Medical Care AG & Co. KGaA |
5008 CorDiax HD-PAED option |
MD: Haemodialysis system, institutional/home-use |
Vk_20180702_08 |
|
16.07.2018 (Updated19.07.2018) |
Frei AG - Aktive Rehasysteme |
Thera - treatment table |
MD: Tables, Examination/Treatment, Adjustable, Physical Therapy |
Vk_20180627_07 |
|
18.07.2018 |
DiaMed GmbH |
Anti-Jka |
IVD: Anti-Jk^a red blood cell grouping IVD, antibody |
Vk_20180711_04 |
|
10.07.2018 (Updated18.07.2018) |
Medtronic MiniMed |
Guardian Connect Application |
MD: Patient health record information system application software |
Vk_20180706_12 |
|
17.07.2018 |
Heraeus Medical GmbH |
COPAL knee moulds |
MD: Orthopaedic cement spacer mould |
Vk_20180716_08 |
|
17.07.2018 |
Biomet Orthopaedics |
Persona Spacer Block Alignment Tower |
MD: Orthopaedic prosthesis implantation instrument, reusable |
Vk_20180712_08 |
|
17.07.2018 |
Lohmann GmbH & Co KG |
Raucodrape camera drape 16x250 in set Kitpack |
MD: Instrument/equipment drape, single-use, non-sterile |
Vk_20180712_01 |
|
17.07.2018 |
Philips Medical Systems DMC GmbH |
Patient Support |
MD: |
Vk_20180711_07 |
|
17.07.2018 |
Teleflex Medical |
Rusch Green Lite (MAC 3) |
MD: Laryngoscope blade, single-use |
Vk_20180710_09 |
|
16.07.2018 |
Intuitive Surgical, Inc |
da Vinci Xi Surgical System |
MD: Robotic surgical system |
Vk_20180702_03 |
|
12.07.2018 |
MicroPort CRM S.r.l. |
PLATINIUM |
AIMD: Single-chamber implantable defibrillator |
Vk_20180712_03 |
|
12.07.2018 |
Etac AS, Etac Supply Gjovik |
Molift 2-point Sling Bar |
MD: Mobile patient lifting system, battery-powered |
Vk_20180706_10 |
|
12.07.2018 |
Draeger Medical Systems, Inc. |
Jaundice meter |
MD: Transcutaneous bilirubinometer |
Vk_20180413_17 |
|
11.07.2018 |
AIR LIQUIDE MEDICAL SYSTEMS |
MONNAL T60 Monnal T60 JP |
MD: Neonatal/adult intensive-care ventilator MD: Transport electric ventilator |
Vk_20180710_04 |
|
11.07.2018 |
Gebr. Gloor AG |
SWISS optio terminal unit DIN |
MD: Medical gas outlet |
Vk_20180710_01 |
|
11.07.2018 |
Haemonetics Corporation |
OPAT RESERVOIR ORTHOPAT INTEGRATED SET |
MD: Blood-processing autotransfusion system set MD: Blood-processing autotransfusion system set |
Vk_20180709_06 |
|
11.07.2018 |
Siemens Healthcare Diagnostics Inc. |
Atellica Solution IM 1300 Analyzer and Atellica Solution IM 1600 Analyzer |
IVD: Chemiluminescent immunoassay analyser IVD, automated |
Vk_20180706_07 |
|
11.07.2018 |
Cepheid AB |
Xpert MTB/RIF Ultra |
IVD: MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT) |
Vk_20180705_09 |
|
11.07.2018 |
Menarini Silicon Biosystems lnc. |
CellSearch Circulating Tumor Cell Kits |
IVD: Radiation therapy treatment record/verify system |
Vk_20180705_03 |
|
11.07.2018 |
OrthoScan Inc |
OrthoScan HD 1000OrthoScan Mini C-Arm X-Ray System |
MD: Portable general-purpose fluoroscopic x-ray system, digital |
Vk_20180704_10 |
|
10.07.2018 |
Philips Medical Systems Nederland BV |
Allura Xper, UNIQ and Centron |
MD: Stationary general-purpose fluoroscopic x-ray system, analogue |
Vk_20180706_03 |
|
10.07.2018 |
Meditrade GmbH |
BeeSana Mullkompresse |
MD: Compresses, Gauze |
2018.08.03
Dear Doctor Letter (Rote-Hand-Brief) on ulipristal acetate (Esmya®): restricted indication, new contraindication and requirements for liver monitoring
Active substance Ulipristalacetat
2018.08.02
Hydroxyethyl-starch containing Medicines: Introduction of new measures to protect patients
Active substance hydroxyethyl starch, HES
2018.07.31
Dear Doctor Letter (Rote-Hand-Brief) on Spinraza (nusinersen): Communicating hydrocephalus not related to meningitis or bleeding reported
Active substance nusinersen
2018.07.20
Retinoids: Updated measures for pregnancy prevention as well as warnings on neuropsychiatric disorders after oral use
Active substance acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene, tretinoin
2018.07.17
Valsartan: Impurity in the active substance
Active substance valsartan
2018.07.06
Information letter on Fiasp® (insulin aspart): New colour scheme for cartridges and pre-filled pens
Active substance insulin aspart
2018.07.05
Dear Doctor Letter (Rote-Hand-Brief) on finasteride: Risk of sexual dysfunction and psychiatric symptoms
Active substance finasterid