Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2023 – 31.03.2023 Швейцарія
Опубліковано 18.04.2023 о 13:51Швейцарія
https://fsca.swissmedic.ch/mep/
28.03.2023 (Updated 03.04.2023) |
Siemens Healthcare Diagnostics Inc. |
ADVIA Centaur Cortisol assay Atellica IM Cortisol |
IVD: Total cortisol IVD, kit, chemiluminescent immunoassay IVD: Total cortisol IVD, kit, chemiluminescent immunoassay |
Vk_20230321_25 |
|
24.03.2023 (Updated 31.03.2023) |
Covidien llc |
Shiley Adult FlexibleTracheostomy Tube |
MD: Tracheostomy tube, non-reinforced, non-customized, single-use |
Vk_20230324_11 |
|
17.03.2023 (Updated 31.03.2023) |
VitreQ B.V. |
CryoTreq |
MD: Ophthalmic cryosurgical system, mechanical |
Vk_20230313_14 |
|
31.03.2023 |
Remote Diagnostic Technologies Ltd. |
Tempus Pro Patient Monitor |
MD: Multiple vital physiological parameter monitoring system, clinical |
Vk_20230221_14 |
|
30.03.2023 |
Ortho Clinical Diagnostics |
Ortho BioVue System Control (RH/K II) Cassette |
IVD: Haematology / Haemostasis / Immunohaematology / Histology / Cytology |
Vk_20230327_01 |
|
28.02.2023 (Updated 30.03.2023) |
MicroPort CRM S.r.l. |
ENO/TEO/OTO/KORA 250 |
AIMD: Dual-chamber implantable pacemaker, demand; Dual-chamber implantable pacemaker, rate-responsive; Single-chamber implantable pacemaker, fixed-rate/demand; Single-chamber implantable pacemaker, rate-responsive |
Vk_20230228_09 |
|
26.07.2021 (Updated 30.03.2023) |
ACUTRONIC Medical Systems AG |
fabian +nCPAP evolution fabian Therapy evolution Fabian HFO |
MD: Neonatal intensive-care ventilator MD: Neonatal intensive-care ventilator MD: Neonatal intensive-care ventilator |
DE-1 |
Vk_20210712_10 |
16.03.2021 (Updated 30.03.2023) |
Medtronic MiniMed |
MiniMed 780G Insulin Pump |
MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm |
Vk_20210316_01 |
|
05.02.2021 (Updated 30.03.2023) |
NuVasive Specialized Orthopedics, Inc. |
PRECICE System |
MD: Long bone distraction rod, magnetic |
DE-1 |
Vk_20210202_09 |
10.03.2023 (Updated 29.03.2023) |
Inpeco S.A. |
Aptio Automation |
IVD: Specimen processing instrument IVD |
Vk_20230303_30 |
|
10.03.2023 (Updated 29.03.2023) |
Inpeco S.A. |
ACCELERATOR a3600 |
IVD: Specimen processing instrument IVD |
Vk_20230303_29 |
|
10.03.2023 (Updated 29.03.2023) |
Inpeco S.A. |
FlexLab |
IVD: Specimen processing instrument IVD |
Vk_20230303_27 |
|
28.03.2023 |
Boston Scientific Corporation |
IntellaNav StablePoint Ablation Catheter |
MD: Cardiac radio-frequency ablation system catheter |
Vk_20230324_20 |
|
27.03.2023 (Updated 28.03.2023) |
Samsung Electronics Co., Ltd |
GM85 |
MD: Mobile basic diagnostic x-ray system, digital |
Vk_20230308_16 |
|
27.03.2023 |
EKU Elektronik GmbH |
NO-Applikationsgerät |
MD: Nitric oxide delivery unit, system-based |
Vk_20230327_35 |
|
27.03.2023 |
Datascope Corp. |
CARDIOSAVE® Hybrid Intra-Aortic Balloon Pump |
MD: Intra-aortic balloon pump |
Vk_20230327_30 |
|
27.03.2023 |
DH Healthcare GmbH |
ORBIS Medication |
MD: General Medicine Instruments – Other |
Vk_20230320_06 |
|
22.03.2023 (Updated 27.03.2023) |
NEXUS / DIS GmbH |
NEXUS / MEDIKATION |
MD: General Medicine Therapeutic Treatment Instruments – Medical Device Software |
Vk_20230223_18 |
|
21.03.2023 (Updated 24.03.2023) |
Draeger Medical Systems, Inc. |
Infinity Central Station Infinity M300/M300+ |
MD: Centralized patient monitor MD: Centralized patient monitor |
Vk_20230320_03 |
|
23.03.2023 |
Medtronic Inc. |
SenSight Extension Tunneler Kit |
AIMD: Subcutaneous tunneller, single-use |
Vk_20230317_14 |
|
23.03.2023 |
EUROIMMUN Medizinische Labordiagnostika AG |
Dengue-Viren-NS1-ELISA |
IVD: Dengue Virus |
Vk_20230316_19 |
|
22.03.2023 |
SPINEART SA |
LATERAL LUMBAR TI-LIFE PLATE |
MD: Spinal fixation plate, non-bioabsorbable |
Vk_20230317_20 |
|
28.02.2023 (Updated 22.03.2023) |
Cook Incorporated |
AdvanceMicro – 14UltraLow-ProfilePTA BalloonCatheter |
MD: Peripheral angioplasty balloon catheter, basic |
Vk_20230227_17 |
|
22.03.2023 |
Spiggle & Theis Medizintechnik GmbH |
ENT single-use suction tubes |
MD: Suction Tips, General-Purpose |
Vk_20220816_12 |
|
02.12.2020 (Updated 22.03.2023) |
Hitachi High-Tech Corporation |
cobas 8000 cobas pro cobas c 513 |
IVD: Multi-modality clinical specimen analysis system IVD IVD: Multi-modality clinical specimen analysis system IVD IVD: Multi-modality clinical specimen analysis system IVD |
Vk_20201130_17 |
|
21.03.2023 |
Molzym GmbH & Co. KG |
Micro-Dx MolYsis-SelectNA Plus |
IVD: Fully Automated Pathogen Diagnosis IVD: Instrument for fully automated microbial DNA extraction |
Vk_20230317_26 |
|
21.03.2023 |
Quidel Corporation |
MicroVue C1-Inhibitor Plus EIA |
IVD: Complement Component C1 inhibitor |
Vk_20230314_18 |
|
14.03.2023 (Updated 16.03.2023) |
Medex |
Qitexio 20ml Luer Lock Syringe |
MD: General-purpose syringe, single-use |
Vk_20230307_25 |
|
16.03.2023 |
Uniogen Oy / Abacus Diagnostica Oy |
GenomEra GBS Assay Kit |
IVD: Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) |
Vk_20230303_38 |
|
07.03.2023 (Updated 16.03.2023) |
Limacorporate S.p.a. |
SMR Glenoid TT MB Peg S-R Medium, Long, X-Long |
MD: Shoulder glenoid fossa prosthesis, prefabricated |
Vk_20230303_36 |
|
15.03.2023 |
Intuitive Surgical, Inc |
Da Vinci X / Xi Surgical System |
MD: Robotic surgical system |
Vk_20230309_12 |
|
15.03.2023 |
Philips Medical Systems DMC GmbH |
CombiDiagnost R90 ProxiDiagnost N90 |
MD: Radiographic/fluoroscopic unit, mobile MD: Radiographic/fluoroscopic unit, mobile |
Vk_20230308_13 |
|
15.03.2023 |
CooperSurgical Inc. |
Global Total LP single step medium |
MD: IVF medium |
Vk_20230215_02 |
|
14.03.2023 |
Siemens Healthcare Diagnostics Inc. |
Atellica DCA Analyzer Atellica DCA ACR Reagent Kit |
IVD: Multichannel clinical chemistry analyser IVD, point-of-care, line-powered IVD: Albumin/creatinine ratio (ACR) IVD, kit, nephelometry/turbidimetry |
Vk_20230310_10 |
|
14.03.2023 |
FUJIFILM medwork GmbH |
Dilatation Balloons (DIL1-A1-Series) |
MD: Dilators |
Vk_20230310_02 |
|
01.03.2022 (Updated 14.03.2023) |
Edwards Critical-Care Division |
Fore-Sight Elite Tissue Oximeter Module Fore-Sight Elite Absolute Tissue Oximeter Monitor |
MD: General-purpose multi-parameter bedside monitor MD: Tissue saturation oximeter |
Vk_20220301_01 |
|
23.02.2023 (Updated 13.03.2023) |
Biosense Webster Inc |
HELIOSTAR Balloon Ablation Catheter |
MD: Cardiac mapping catheter, percutaneous, single-use |
Vk_20230216_10 |
|
10.03.2023 |
Aesculap AG |
CAIMAN, Endoscopic electrosurgical handpiece |
MD: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use |
Vk_20230309_10 |
|
10.03.2023 |
Armstrong Medical Limited |
AquaVent Neo Neonatal Heated CPAP System |
MD: Ventilator breathing circuit, single-use |
Vk_20230306_15 |
|
10.03.2023 |
Waldemar Link GmbH & Co. KG |
Link Sled Prosthesis – Femoral Components & Tibial Plateaus |
MD: Uncoated unicondylar knee femur prosthesis; Coated unicondylar knee femur prosthesis; Uncoated unicondylar knee tibia prosthesis, polyethylene; Uncoated unicondylar knee tibia prosthesis, metallic; Coated unicondylar knee tibia prosthesis |
Vk_20230301_03 |
|
02.03.2023 (Updated 10.03.2023) |
Ganshorn Medizin Electronic GmbH |
Spirometer-diagnostics |
MD: Diagnostic spirometer, professional |
Vk_20230227_14 |
|
06.03.2023 (Updated 10.03.2023) |
HYPHEN BioMed SAS |
BIOPHEN PROTEIN C LRT |
IVD: Coagulation Inhibitors/thrombophilia Markers |
Vk_20230223_13 |
|
28.02.2023 (Updated 10.03.2023) |
Philips Medical Systems Nederland B.V |
SmartPerfusion; 2D Perfusion |
MD: Stationary general-purpose fluoroscopic x-ray system, analogue |
Vk_20230221_28 |
|
05.01.2023 (Updated 10.03.2023) |
Siemens Healthcare GmbH |
Luminos dRF Max |
MD: Stationary general-purpose fluoroscopic x-ray system, digital |
Vk_20221221_12 |
|
09.03.2023 |
Philips Healthcare (Suzhou) Co., Ltd. |
DigitalDiagnost |
MD: Stationary basic diagnostic x-ray system, digital |
Vk_20230301_24 |
|
08.03.2023 |
Ottobock SE & Co. KGaA |
Genu Arexa PCL |
MD: Knee support orthosis |
Vk_20230302_14 |
|
08.03.2023 |
Radiometer Medical |
AQURE system |
IVD: Medical equipment clinical data interfacing software |
Vk_20230301_23 |
|
08.03.2023 |
Hamilton Bonaduz AG |
Hamilton-C6 |
MD: Respiratory And Anaesthesia Devices – Other |
Vk_20230208_14 |
|
04.10.2022 (Updated 08.03.2023) |
DiaMed GmbH |
IH-500 |
IVD: Immunohaematology/blood bank analyser IVD |
Vk_20220921_01 |
|
07.03.2023 |
MAQUET Cardiopulmonary GmbH |
Heater-Cooler Unit HCU 40 High Voltage |
MD: Cardiopulmonary bypass system heat exchanger, reusable |
Vk_20230306_19 |
|
07.03.2023 |
Brainlab AG |
Cirq Arm System 2.0 |
MD: Surgical instrument assist arm system, power-adjusted |
Vk_20230306_18 |
|
07.03.2023 |
Boston Scientific Corporation |
Habib EndoHPB Bipolar Radiofrequency Catheter |
MD: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use |
Vk_20230303_01 |
|
07.03.2023 |
HUMAN Gesellschaft für Biochemica und Diagnostica mbH |
IMTEC CIC IgG ELISA |
IVD: Circulating immune complex kit |
Vk_20230302_01 |
|
07.03.2023 |
Avanos Medical, lnc. |
BALLARD* Oral Care Swabs |
MD: Oral care kit, single-use |
DE-1-CUST |
Vk_20230301_08 |
14.02.2023 (Updated 07.03.2023) |
Caesarea Medical Electronics Limited |
BD BodyGuard MicroSets |
MD: Electric infusion pump administration set, Blood transfusion set, Intravenous administration tubing extension set |
Vk_20230207_14 |
|
30.12.2022 (Updated 07.03.2023) |
Medtronic Inc. |
Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface |
MD: Extracorporeal membrane oxygenator |
Vk_20221221_01 |
|
06.03.2023 |
St. Jude Medical |
Trifecta Valve |
MD: Aortic heart valve bioprosthesis |
Vk_20230227_28 |
|
03.03.2023 |
ENDALIS |
End-ball ENDT110 |
MD: Appetite-suppression gastric balloon |
Vk_20220607_17 |
|
09.02.2022 (Updated 02.03.2023) |
PULSION Medical Systems SE |
PiCCO Monitoring Kit + ProAQT Sensor |
MD: Invasive blood pressure transducer set |
Vk_20220203_28 |
|
01.03.2023 |
RAL Diagnostics |
MCDh1 |
IVD: Biological stain IVD |
Vk_20230214_05 |
|
24.08.2022 (Updated 01.03.2023) |
Planer Limited |
Humidifier Bottle and Syringe filter kit for BT37 |
MD: Non-heated respiratory humidifier |
Vk_20220815_17 |
|
28.02.2023 |
Gynemed GmbH & Co. KG |
Denu Tips Oocyte aspiration Needles |
MD: Assisted reproduction microtool MD: IVF oocyte aspiration needle, single-use |
Vk_20230223_14 |
|
28.02.2023 |
Siemens Healthcare Diagnostics Inc. |
ADVIA Autoslide Giemsa Stain |
IVD: Giemsa staining solution IVD |
Vk_20230221_15 |
|
23.02.2023 (Updated 28.02.2023) |
Rehasense Sp z o.o. |
Router, Navigator, EVA, Navigon |
MD: Walkers, Wheeled |
Vk_20230214_17 |
|
27.09.2022 (Updated 28.02.2023) |
Siemens Healthcare Diagnostics Inc. |
Lithium (Li) reagents Lithium_2 (LITH_2) reagents |
IVD: Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy IVD: Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy |
Vk_20220921_10 |
|
20.02.2023 (Updated 27.02.2023) |
Abbott Diabetes Care Ltd |
FreeStyle Libre 3 App FreeStyle LibreLink App |
MD: Percutaneous interstitial-fluid glucose monitoring system, electrochemical MD: Percutaneous interstitial-fluid glucose monitoring system, electrochemical |
DE-1.1 |
Vk_20230210_14 |
09.01.2023 (Updated 27.02.2023) |
Inari Medical, Inc. |
Triever24 |
MD: Thrombectomy suction catheter |
Vk_20221229_11 |
|
03.08.2022 (Updated 27.02.2023) |
Medtronic Inc. |
Vanta LT Clinician Programmer Application |
AIMD: Multiple active implantable device programmer |
Vk_20220729_03 |
|
03.08.2022 (Updated 27.02.2023) |
Medtronic Inc. |
Vanta LT Clinician Programmer Application |
AIMD: Multiple active implantable device programmer |
Vk_20220729_02 |
|
24.02.2023 |
Drägerwerk AG & Co. KGaA |
ICM |
MD: Data Management Systems, Patient |
Vk_20230214_22 |
|
30.01.2023 (Updated 24.02.2023) |
DiaMed GmbH |
IH-1000 |
IVD: Immunohaematology/blood bank analyser IVD |
Vk_20230123_27 |
|
22.02.2023 |
CareDx AB |
Olerup QTYPE 11 |
IVD: Hla Antigen Typing |
Vk_20230222_12 |
|
08.02.2023 (Updated 22.02.2023) |
Randox Laboratories Ltd |
Randox CRP |
IVD: C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry |
Vk_20230206_18 |
|
21.02.2023 |
B. Braun Melsungen AG |
INF.SP.LINE, TRANS, PVC, LL, 250CM-EU |
MD: Electric infusion pump administration set, single-use |
Vk_20230202_20 |
|
21.02.2023 |
Carnamedica Sp. z o.o. |
StoreProtect Belzer UW Cold Storage Solution Belzer MPS |
MD: General-purpose donor-organ preservation/transport system MD: General-purpose donor-organ preservation/transport system MD: General-purpose donor-organ preservation/transport system |
Vk_20230125_09 |
|
20.02.2023 |
SINOVO health solutions GmbH |
mylife App |
MD: General Medicine Diagnosis And Monitoring Instruments |
Vk_20230215_01 |
|
20.02.2023 |
Siemens Healthcare Diagnostics Products GmbH |
Test Thrombin Reagent |
IVD: Thrombin time (TT) IVD, kit, clotting |
Vk_20230213_26 |
|
17.02.2023 |
Nidek & Co Ltd |
Preloaded EyeCee One IOL |
MD: Posterior-chamber intraocular lens, pseudophakic |
Vk_20230209_11 |
|
17.02.2023 |
Telemis S.A. |
Telemis-Medical |
MD: Picture Archiving And Communication Systems |
Vk_20230131_16 |
|
17.02.2023 |
Emergent BioSolutions Inc |
Reactive Skin Decontamination Lotion (RSDL) |
MD: Towelettes, Personal, Skin/Personal Gear Decontamination |
Vk_20230113_05 |
|
15.02.2023 |
Medtronic Sofamor Danek Inc. |
Grafton Putty, Grafton Crunch, Grafton Flex, Grafton Orthoblend, Grafton Matrix, Grafton Matrix Strips, Grafton Plus Paste, Grafton DBF, Grafton DBF Inject, Grafton Gel, Accelerate Grafton DB, XPANSE Bone Insert |
: Demineralized bone allografts |
Vk_20230209_31 |
|
15.02.2023 |
Given Imaging Inc. |
SmartPill SmartBar |
MD: Gastrointestinal telemetric monitoring system |
Vk_20230208_27 |
|
14.02.2023 |
St. Jude Medical |
CardioMEMS PA Sensor and Delivery System |
AIMD: Implantable pulmonary artery pressure monitoring system |
Vk_20230208_16 |
|
14.02.2023 |
St. Jude Medical |
CardioMems Hospital and Patient Electronic System |
AIMD: Implantable pulmonary artery pressure monitoring system |
Vk_20230208_15 |
|
08.02.2023 (Updated 10.02.2023) |
Mobidiag Ltd. |
Novodiag CarbaR+ |
IVD: Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) |
Vk_20230202_13 |
|
16.01.2023 (Updated 10.02.2023) |
Respironics Inc. |
V680 Ventilator |
MD: General-purpose intensive-care ventilator |
Vk_20230116_17 |
|
08.02.2023 (Updated 09.02.2023) |
Physio-Control, Inc. |
LIFEPAK CR2 defibrillator |
MD: Non-rechargeable public semi-automated external defibrillator |
Vk_20230203_21 |
|
09.02.2023 |
TRACOE medical GmbH |
TRACOE experc Set twist TRACOE experc Set vario TRACOE experc Set twist plus |
MD: Tracheostomy kit, single-use MD: Tracheostomy kit, single-use MD: Tracheostomy kit, single-use |
Vk_20230131_11 |
|
06.12.2022 (Updated 09.02.2023) |
Medtronic Inc. |
Vanta LT Clinician Programmer Application |
AIMD: Multiple active implantable device programmer |
Vk_20221130_18 |
|
08.02.2023 |
Beckman Coulter , Inc. |
Access 2 Immunoassay Analyzer Access 2 Immunoassay Analyzer, Refurbished Access 2 Immunoassay Analyzer-Refurbished Access 2 Section, DxC 600i Packaged |
IVD: Chemiluminescent immunoassay analyser IVD IVD: Chemiluminescent immunoassay analyser IVD IVD: Chemiluminescent immunoassay analyser IVD IVD: Chemiluminescent immunoassay analyser IVD |
Vk_20230203_06 |
|
07.02.2023 |
DH HealthCare GmbH |
ORBIS Medication |
MD: General Medicine Instruments – Other |
Vk_20230206_17 |
|
07.02.2023 |
Intuitive Surgical, Inc |
SureForm 45, SureForm 45 Curved-Tip, SureForm 60 |
MD: Robotic surgical cutting stapler, single-use |
Vk_20230206_16 |
|
07.02.2023 |
Siemens Healthcare GmbH |
ARTIS pheno |
MD: Stationary angiographic x-ray system, digital |
Vk_20230202_29 |
|
07.02.2023 |
GE Healthcare Finland Oy |
Frame F2-01 |
MD: Patient monitoring system module rack |
Vk_20230201_02 |
|
01.12.2022 (Updated 07.02.2023) |
Clinical Innovations LLC |
Fetal Measurements |
MD: Foetal scalp electrode, spiral |
Vk_20221124_25 |
|
06.02.2023 |
bioMérieux SA |
Mueller Hinton E Agar |
IVD: Mueller-Hinton agar antimicrobial susceptibility culture medium IVD |
Vk_20230125_01 |
|
03.02.2023 |
Miele & Cie. KG |
Steelco PWD |
MD: Cleaning And Disinfection Equipment |
Vk_20230126_01 |
|
01.02.2023 (Updated 02.02.2023) |
Siemens Healthcare Diagnostics Inc. |
Atellica CH LDL Cholesterol Direct (DLDL) Atellica CH Total Protein II (TP) Atellica CH Triglycerides (Trig) Atellica CH Triglycerides_2 (Trig)_2 |
IVD: Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry IVD: Total protein IVD, kit, enzyme spectrophotometry IVD: Triglyceride IVD, kit, enzyme spectrophotometry IVD: Triglyceride IVD, kit, enzyme spectrophotometry |
Vk_20230127_24 |
|
02.02.2023 |
Covidien llc |
Tri-Staple 2.0 |
MD: Surgical staple loading unit, non-cutting |
Vk_20230125_23 |
|
31.01.2023 (Updated 02.02.2023) |
Ivor Shaw Ltd. trading as Pennine Healthcare |
Link Yankauer Sets Suction Connecting Tubing |
MD: Surgical/emergency suction cannula, non-illuminating, single-use MD: Suction/irrigation tubing, single-use |
Vk_20230124_01 |
|
31.01.2023 |
Drägerwerk AG & Co. KGaA |
Flex Ventilation Hose |
MD: Tubing |
Vk_20230127_21 |
|
30.01.2023 (Updated 31.01.2023) |
Weinmann Emergency Medical Technology GmbH + Co. KG |
MEDUMAT Standard 2 |
MD: Transport electric ventilator |
Vk_20230117_08 |
|
27.06.2019 (Updated 31.01.2023) |
Datascope Corp. |
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump |
MD: Intra-aortic balloon pump |
Vk_20190619_15 |
|
22.03.2022 (Updated 30.01.2023) |
ELITech Clinical Systems SAS |
MAGNESIUM XB |
IVD: Magnesium (Mg2+) IVD, kit, spectrophotometry |
Vk_20220317_02 |
|
08.03.2022 (Updated 30.01.2023) |
Abbott Molecular Inc. |
Alinity m HBV AMP Kit |
IVD: Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) |
Vk_20220308_02 |
|
21.12.2022 (Updated 27.01.2023) |
Phadia AB |
Phadia 200, Fluorescent immunoassay analyser IVD, laboratory |
IVD: Fluorescent immunoassay analyser IVD, laboratory |
Vk_20221213_28 |
|
23.01.2023 (Updated 26.01.2023) |
Scewo AG |
Scewo Bro |
MD: Wheelchairs, Powered |
Vk_20230116_18 |
|
27.12.2022 (Updated 26.01.2023) |
Philips Goldway (Shenzhen) Industrial Inc. |
Efficia External Padles |
MD: External defibrillator electrode, adult, reusable |
Vk_20221223_03 |
|
25.01.2023 |
Schiller AG |
CARDIOVIT MS-2007; MS-2010; MS-2015 CARDIOVIT AT-102 CARDIOVIT AT-10 plus CARDIOVIT AT-104 PC CARDIOVIT CS-200 CARDIOVIT AT-102 plus |
MD: Electrocardiograph, professional, multichannel MD: Electrocardiograph, professional, multichannel MD: Electrocardiograph, professional, multichannel MD: Electrocardiograph, professional, multichannel MD: Electrocardiograph, professional, multichannel MD: Electrocardiograph, professional, multichannel |
Vk_20230124_11 |
|
24.01.2023 (Updated 25.01.2023) |
Rayner Intraocular Lenses Limited |
RayOne EMV |
MD: Posterior-chamber intraocular lens, pseudophakic |
Vk_20230124_09 |
|
25.01.2023 |
Drägerwerk AG & Co. KGaA |
NovaStar plus, Nova Star TS |
MD: Masks |
Vk_20230120_16 |
|
25.01.2023 |
Teleflex Medical SDN BHD |
Rüsch EndoGuide T |
MD: Endotracheal tube introducer, single-use |
Vk_20230120_01 |
|
25.01.2023 |
Medtronic MiniMed |
MiniMed 508 Insulin Pump MiniMed Paradigm Veo MiniMed Paradigm Insulin Pump |
MD: Ambulatory insulin infusion pump, electronic MD: Ambulatory insulin infusion pump, electronic MD: Ambulatory insulin infusion pump, electronic |
Vk_20230119_18 |
|
25.01.2023 |
B. Braun Melsungen AG |
PROSET MULTIPACK SYRINGES |
MD: Intravenous line stopcock |
Vk_20230117_07 |
|
22.02.2022 (Updated 25.01.2023) |
RaySearch Laboratories AB (publ) |
RayStation |
MD: Radiation therapy software |
DE-1 Information Only |
Vk_20220217_70 |
23.01.2023 |
FUJIFILM Irvine Scientific, Inc |
Oil for Embryo Culture |
MD: Devices For Assisted Reproduction |
Vk_20230123_09 |
|
30.11.2022 (Updated 23.01.2023) |
X-Nav Technologies, LLC |
X-Guide System X-Mark Probe Tool |
MD: Surgical Navigation Instruments – Hardware Accessories |
Vk_20221124_06 |
|
20.01.2023 |
AIR LIQUIDE MEDICAL SYSTEMS |
MONNAL T60 MONNAL T60 Advanced |
MD: Transport electric ventilator MD: Transport electric ventilator |
Vk_20230111_03 |
|
19.01.2023 |
B. Braun Melsungen AG |
Original Perfusor Line |
MD: Intravenous administration tubing extension set |
Vk_20230116_20 |
|
12.01.2023 (Updated 19.01.2023) |
Johnson & Johnson International |
Coated VICRYL PLUS – Antibacterial suture |
MD: Polyester suture, bioabsorbable, multifilament, antimicrobial |
Vk_20230104_05 |
|
24.11.2022 (Updated 19.01.2023) |
VWR International |
FORMALIN 10% Buffered Q Path |
IVD: Fixative, formalin |
Vk_20221109_13 |
|
18.01.2023 |
B. Braun Melsungen AG |
INF.SP.LINE, TRANS, PVC, LL, 250CM-EU |
MD: Electric infusion pump administration set, single-use |
Vk_20230111_21 |
|
17.01.2023 |
Sofradim Production |
PARIETEX |
MD: Extra-gynaecological surgical mesh, composite-polymer |
Vk_20230111_20 |
|
10.01.2023 (Updated 16.01.2023) |
Roche Diagnostics GmbH |
Elecsys Troponin T hs Elecsys Troponin-T hs STAT |
IVD: Troponin I/t IVD: Troponin I/t |
Vk_20230109_15 |
|
09.01.2023 (Updated 16.01.2023) |
GENERI BIOTECH s.r.o |
gb PHARM UGT1A1 |
IVD: Inborn Gene Or Chromosome Alterations |
Vk_20221223_01 |
|
27.12.2022 (Updated 16.01.2023) |
GENERI BIOTECH s.r.o |
gb PHARM UGT1A1 |
IVD: Inborn Gene Or Chromosome Alterations |
Vk_20221221_33 |
|
19.12.2022 (Updated 16.01.2023) |
VacSax Limited |
Vommax |
MD: Fluid Collection Bags And Systems – Other |
Vk_20221219_13 |
|
17.09.2021 (Updated 16.01.2023) |
Datascope Corp. |
Cardiosave Hybrid/Rescue IABP |
MD: Intra-aortic balloon pump |
Vk_20210913_06 |
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