https://fsca.swissmedic.ch/mep/#/
|
09.2021 (Updated 05.10.2021) |
Cook Incorporated |
Flexor Check-Flo Introducer |
MD: Vascular catheter introduction set, nonimplantable |
Vk_20210924_05 |
|
|
04.08.2021 (Updated 05.10.2021) |
Welch Allyn Inc |
Braun ThermoScan PRO 6000 |
MD: Infrared patient thermometer, ear |
Vk_20210728_05 |
|
|
04.10.2021 |
Schiller AG |
FRED Easyport |
MD: Non-rechargeable public semi-automated external defibrillator |
Vk_20210928_09 |
|
|
21.09.2021 (Updated 04.10.2021) |
Ophtec BV |
Artiflex Artisan |
MD: Anterior-chamber intraocular lens, phakic MD: Anterior-chamber intraocular lens, phakic |
Vk_20210920_10 |
|
|
01.10.2021 |
ZOLL Circulation |
Cool Line Catheter CL-2295 AE Quattro IVTM Catheter Solex 7 Catheter ZOLL IVTM ICY Catheter |
MD: Intravascular heating/cooling system catheter MD: Intravascular heating/cooling system catheter MD: Intravascular heating/cooling system catheter MD: Intravascular heating/cooling system catheter |
Vk_20210927_13 |
|
|
29.09.2021 |
VIRCELL |
TETANUS VIRCLIA IgG MONOTEST |
IVD: Tetanus (Clostridium T.) |
Vk_20210924_23 |
|
|
21.09.2021 (Updated 29.09.2021) |
Medtronic Inc. |
Activa Clinician Programmer Application |
AIMD: Multiple active implantable device programmer |
Vk_20210916_11 |
|
|
28.09.2021 |
MEDTECH |
ROSA One |
MD: Multi-purpose stereotactic surgery system |
Vk_20210924_07 |
|
|
28.09.2021 |
ResMed Ltd. |
AcuCare hospital full face masks |
MD: CPAP/BPAP face mask, single-use |
Vk_20210922_16 |
|
|
08.09.2021 (Updated 27.09.2021) |
Agilent Technologies Singapore Pte Ltd. |
EnVision FLEX Hematoxylin (Link) |
IVD: Biological stain IVD |
Vk_20210903_21 |
|
|
21.09.2021 (Updated 24.09.2021) |
Advanced Surgical Concepts Ltd. |
PneumoLiner |
MD: Trocars, Abdominal; Cavity Liners |
Vk_20210921_01 |
|
|
17.09.2021 (Updated 24.09.2021) |
Datascope Corp. |
Cardiosave Hybrid/Rescue IABP |
MD: Intra-aortic balloon pump |
Vk_20210913_06 |
|
|
08.09.2021 (Updated 24.09.2021) |
DJO, LLC |
CHATTANOOGA ultrasound gel and lotions |
MD: Coupling gel, non-sterile |
Vk_20210830_19 |
|
|
14.09.2021 (Updated 23.09.2021) |
RaySearch Laboratories AB (publ) |
RayStation |
MD: Radiation therapy software |
Vk_20210913_19 |
|
|
21.09.2021 (Updated 23.09.2021) |
Exactech Inc. |
Exactech Knee and Ankle UHMWPE inserts |
MD: Logic CRC Insert; Logic CR Insert; Logic PS Tibia, Modinsert; Ankle Prim Mobile Liner |
Vk_20210906_17 |
|
|
22.09.2021 |
Herdegen SAS |
Advance EVOLUTION, FUN |
MD: Elbow crutch MD: Elbow crutch |
Vk_20210916_07 |
|
|
21.09.2021 |
William Cook Europe ApS |
Inferior Vena Cava (IVC) Filter |
MD: Vena cava filter, temporary/permanent |
Vk_20210915_11 |
|
|
21.09.2021 |
Elekta Limited |
Linear Accelerator |
MD: Linear accelerator system |
Vk_20210915_10 |
|
|
20.09.2021 |
William A. Cook Australia Pty Ltd. |
Single Lumen and Double Lumen Ovum Pick-Up Needles |
MD: Body aspiration needle, single-use |
Vk_20210908_21 |
|
|
01.09.2021 (Updated 15.09.2021) |
MAQUET Cardiopulmonary GmbH |
HCU40 |
MD: Cardiopulmonary bypass system heat exchanger, reusable |
Vk_20210825_03 |
|
|
14.09.2021 |
bioMerieux Inc |
MYLA |
IVD: Laboratory instrument/analyser application software IVD |
Vk_20210913_16 |
|
|
14.09.2021 |
Philips Medical Systems |
Infant/Child SMART Pads Cartridge |
MD: External defibrillator electrode, paediatric, single-use |
Vk_20210909_05 |
|
|
14.09.2021 |
Atrium Medical Corporation |
Atrium Pneumostat Chest Drain Valve |
MD: Closed-wound/centesis drainage receptacle |
Vk_20210901_05 |
|
|
13.09.2021 |
Inpeco S.A. |
Aptio Automation |
IVD: Specimen processing instrument IVD, automated |
Vk_20210913_09 |
|
|
06.09.2021 (Updated 13.09.2021) |
Abbott Molecular Inc. |
Alinity m Resp-4-Plex Amplification Reagent Kit Alinity m SARS-CoV-2 Amplification Reagent Kit |
IVD: Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) IVD: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
Vk_20210906_01 |
|
|
13.09.2021 |
Laboratoire CCD |
1ml IVF and AI Syringes |
MD: General-purpose syringe, single-use |
Vk_20210903_28 |
|
|
10.09.2021 |
GE Healthcare |
Centricity Universal Viewer |
MD: Medical image management system |
Vk_20210903_26 |
|
|
07.09.2021 (Updated 10.09.2021) |
Thermo Fisher Scientific Microbiology Basingstoke |
ThermoScientificTM OxoidTM Egg Yolk Emulsion |
IVD: Culture medium supplement, enriched |
Vk_20210901_11 |
|
|
25.08.2021 (Updated 10.09.2021) |
Chalice Medical Ltd |
Paratherm |
MD: Extracorporeal cardiopulmonary support system heating/cooling unit |
Vk_20210820_20 |
|
|
08.09.2021 (Updated 10.09.2021) |
Roche Diagnostics GmbH |
TDM parameters on cobas c 503 analytical unit |
IVD: Multi-modality clinical specimen analysis system IVD |
Vk_20201127_04 |
|
|
08.09.2021 |
Datex-Ohmeda, Inc (GE Healthcare) |
Flow Sensors used in the GEHC anesthesia machines |
MD: Anaesthesia workstation, general-purpose |
Vk_20210901_10 |
|
|
08.09.2021 |
Medtronic Xomed |
Sterile Blade Single-Use Accessories |
MD: Orthopaedic bur, single-use |
Vk_20210831_19 |
|
|
02.09.2021 |
Baxter Healthcare SA |
PrisMax, V2, ROW PrisMax V2 TO PrisMax V3 UPGRADE KIT |
MD: Haemodialysis system, institutional MD: Haemodialysis system, institutional |
Vk_20210826_12 |
|
|
17.08.2021 (Updated 02.09.2021) |
HeartWare Inc. |
HeartWare Ventricular Assist System - HVAD Pump Implant Kit |
AIMD: Implantable ventricular circulatory assist system |
Vk_20210816_15 |
|
|
23.08.2021 (Updated 02.09.2021) |
Beckman Coulter , Inc. |
Access hsTnI Reagent (High Sensitivity Troponin I) |
IVD: Troponin I IVD, kit, chemiluminescent immunoassay |
Vk_20210809_09 |
|
|
01.09.2021 |
SEBIA |
CAPI 3 IMMUNOTYPING |
IVD: Multiple clinical chemistry protein IVD, reagent |
Vk_20210830_09 |
|
|
01.09.2021 |
Chromsystems Instruments & Chemicals GmbH |
96 Deep Well Filter Plates of MassTox Immunosuppressants in whole blood - ONEMINUTE Test |
IVD: Microplate IVD |
Vk_20210830_02 |
|
|
01.09.2021 |
Roche Diagnostics GmbH |
cobas EGFR Mutation Test, v2 IVD |
IVD: Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) |
Vk_20210827_15 |
|
|
31.08.2021 (Updated 01.09.2021) |
Dräger Medical GmbH |
Atlan |
MD: Anesthesia Units |
Vk_20210827_10 |
|
|
01.09.2021 |
Medtronic Inc. |
DLP Left Heart Vent |
MD: Cardiopulmonary bypass cannula, arterial |
Vk_20210824_08 |
|
|
31.08.2021 |
W. L. Gore & Associates |
GORE CARDIOFORM Septal Occluder |
MD: Cardiac occluder |
Vk_20210831_04 |
|
|
31.08.2021 |
Drägerwerk AG & Co.KGaA |
Babylog VN500 Evita |
MD: Neonatal/adult intensive-care ventilator MD: Ventilators, Intensive Care |
Vk_20210827_07 |
|
|
31.08.2021 |
GE Healthcare |
Centricity PACS-IW with Universal Viewer |
MD: Medical image management system |
Vk_20210826_24 |
|
|
31.08.2021 |
Philips Medical Systems Nederland BV |
Ingenia & SmartPath to dStream MRI |
MD: Full-body MRI system, superconducting magnet |
Vk_20210824_10 |
|
|
27.08.2021 (Updated 30.08.2021) |
CAIR LGL |
Polyurethane enteral feeding tubes |
MD: Nasogastric/orogastric tube |
Vk_20210811_01 |
|
|
10.08.2021 (Updated 27.08.2021) |
GS Elektromedizinische Geräte G. Stemple GmbH |
corpuls3 corpuls3 Touch |
MD: Physiologic-monitoring defibrillation system MD: Physiologic-monitoring defibrillation system |
Vk_20210804_25 |
|
|
08.06.2021 (Updated 27.08.2021) |
Medtronic Inc. |
LINQ II Insertable Cardiac Monitor |
AIMD: Implantable cardiac monitor |
Vk_20210602_17 |
|
|
26.08.2021 |
Caesarea Medical Electronics Limited |
BodyGuard Infusion Pumps Systems (LVP) |
MD: Multichannel general-purpose infusion pump |
Vk_20210823_05 |
|
|
25.08.2021 |
Siemens Healthcare GmbH |
syngo.via RT Image Suite |
MD: CT system application software |
DE-1 (CT042) |
Vk_20210820_22 |
|
25.08.2021 |
A.M.I. Agency for Medical Innovations GmbH |
i-Cut |
MD: Tissue morcellation system handpiece, line-powered |
Vk_20210820_15 |
|
|
25.08.2021 |
Karl Storz SE & Co.KG |
FIVE S 3, 5x65, steril zum Einmalgebrauch |
MD: Flexible video intubation laryngoscope, single-use |
Vk_20210817_13 |
|
|
24.08.2021 |
Medline Industries Inc. |
Namic Sterile Stopcock and Manifolds |
MD: Stopcock |
Vk_20210819_18 |
|
|
23.08.2021 |
Henry Schein Inc. |
Peripheral venous catheter set with and without safety |
MD: Winged needle infusion set, I.V. catheter with port and with and without wings, Obturator |
Vk_20210811_05 |
|
|
20.08.2021 |
Hillrom |
OctoStretch with Stretch Leveler FlexoStretch Stretch Leveller LikoStretch 1900 LikoStretch Mod 600 IC |
MD: Patient lifting system stretcher MD: Patient lifting system stretcher MD: Accessory MD: Patient lifting system stretcher MD: Patient lifting system stretcher |
Vk_20210810_12 |
|
|
19.08.2021 (Updated 20.08.2021) |
Laboratoires ANIOS (ECOLAB) |
Module Endoscopique HDAI and HDE |
MD: sink |
Vk_20210803_15 |
|
|
19.08.2021 |
CareFusion |
Illinois Bone Marrow Aspiration/ Intraosseous Needle, 15G x 79mm |
MD: Bone marrow biopsy needle, single-use |
Vk_20210812_19 |
|
|
13.07.2021 (Updated 19.08.2021) |
Xstrahl Ltd |
Xstrahl |
MD: Stationary orthovoltage therapeutic x-ray system |
Vk_20210709_01 |
|
|
24.06.2021 (Updated 19.08.2021) |
Fritz Stephan GmbH |
Eve In Eve Tr Eve Neo |
MD: Adult And Paediatric/neonatal Pulmonary Ventilators MD: Adult And Paediatric/neonatal Pulmonary Ventilators MD: Adult And Paediatric/neonatal Pulmonary Ventilators |
Vk_20210617_18 |
|
|
18.08.2021 |
Beckman Coulter Biomedical GmbH |
DxA 5000 |
IVD: Automated sample handling system |
Vk_20210811_14 |
|
|
18.08.2021 |
Thermofisher Scientific |
RapID NF PLUS System |
IVD: Bacteria identification |
Vk_20210811_09 |
|
|
25.06.2021 (Updated 18.08.2021) |
G. Heinemann Medizintechnik GmbH |
MODULA |
MD: ENT cabinet |
Vk_20210615_21 |
|
|
17.08.2021 |
HOYA Corp. |
PENTAX Video Duodenoscope |
MD: Flexible video duodenoscope, reusable |
Vk_20210812_20 |
|
|
03.08.2021 (Updated 16.08.2021) |
SSI Diagnostica A/S |
Immuview S. pneumoniae and L. pneumophila urinary antigen test |
IVD: Bacteriology (Infect. Immunology) |
Vk_20210729_21 |
|
|
26.07.2021 (Updated 16.08.2021) |
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 |
Vk_20210712_10 |
|
|
13.08.2021 |
Disposan AG |
Saliva Ersatz Kit Disposan |
IVD: Sampling Kits |
Vk_20210813_14 |
|
|
13.08.2021 |
Brightwake Limited |
Activon Tube Algivon Honey Dressing |
MD: Wound-nonadherent dressing, permeable, antimicrobial MD: Wound-nonadherent dressing, permeable, antimicrobial |
Vk_20210810_19 |
|
|
06.02.2019 (Updated 12.08.2021) |
Philips Medical Systems |
Philips PageWriter TC Cardiographs (TC20/30/50/70) |
MD: Electrocardiograph, professional, multichannel |
Vk_20190123_09 |
|
|
11.08.2021 |
Philips Medical Systems DMC GmbH |
CombiDiagnost R90 |
MD: Radiographic/fluoroscopic unit, mobile |
Vk_20210809_08 |
|
|
11.08.2021 |
Philips Medical Systems DMC GmbH |
CombiDiagnost R90 R1.1, Upgrades for CombiDiagnost R90 |
MD: Radiographic/fluoroscopic unit, mobile |
Vk_20210809_07 |
|
|
11.08.2021 |
Elekta, Inc. |
Monaco RTP System |
MD: Radiation therapy software |
Vk_20210806_10 |
|
|
11.08.2021 |
Philips Ultrasound Inc. |
EPIQ Ultrasound System |
MD: General-purpose ultrasound imaging system |
Vk_20210805_03 |
|
|
03.08.2021 (Updated 11.08.2021) |
Olympus Medical Systems Corp. |
Forceps/Irrigation Plug (Isolated Type) |
MD: Endoscopic procedure air/water valve, reusable |
Vk_20210729_25 |
|
|
11.08.2021 |
Promedon S.A. |
Metal semi rigid injection needle |
MD: Submucosal injection needle |
Vk_20210726_18 |
|
|
10.08.2021 |
Altomed Limited |
Damato Ruthenium Plaque Template |
MD: Eye brachytherapy plaque-/applicator-positioning template |
Vk_20210805_11 |
|
|
10.08.2021 |
bioMérieux SA |
VIDAS EBV VCA IGM |
IVD: Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) |
Vk_20210803_04 |
|
|
10.08.2021 |
Fresenius Kabi Deutschland GmbH |
Exelia Combox Exelia Therapy Manager Exelia VP |
MD: Syringe pump MD: Infusion pump management unit, mobile MD: General-purpose infusion pump, line-powered |
Vk_20210802_04 |
|
|
10.08.2021 |
Verathon Medical Inc. |
GlideScope Go Monitor |
MD: handheld video monitor |
Vk_20210729_09 |
|
|
10.08.2021 (Updated 10.08.2021) |
HS Doms GmbH |
HSM 600 |
MD: Tables, Instrument |
Vk_20210727_14 |
|
|
15.07.2021 (Updated 10.08.2021) |
Nobel Biocare AB |
Full Contour Zirconia (FCZ) Implant Crown |
MD: Dental implant suprastructure, permanent, preformed |
Vk_20210623_02 |
|
|
04.08.2021 (Updated 09.08.2021) |
Abbott Laboratories |
Alinity ci-series System Control Module |
IVD: Chemiluminescent immunoassay analyser IVD, automated |
Vk_20210729_15 |
|
|
10.03.2021 (Updated 09.08.2021) |
B. Braun Surgical, S.A. |
HISTOACRYL BLUE/ LAPFIX/PROSET OFX |
MD: Surgical adhesive/sealant, synthetic polymer |
Vk_20210304_05 |
|
|
27.07.2021 (Updated 05.08.2021) |
HemoSonics, LLC |
Qplus Cartridges |
IVD: Other Haemostasis RT & POC |
Vk_20210722_23 |
|
|
24.03.2021 (Updated 05.08.2021) |
Medtronic Inc. |
Activa Clinician Programmer Application |
AIMD: Multiple active implantable device programmer |
Vk_20210316_15 |
|
|
04.08.2021 |
Leica Biosystems Newcastle Ltd |
BOND Ready-to-Use Primary Antibody CDX2 (EP25) |
IVD: Homeobox protein CDX-2 IVD, antibody |
Vk_20210802_14 |
|
|
04.08.2021 |
Dräger Medical AG & Co. KGaA |
Zeus Infinity Empowered |
MD: Anaesthesia unit |
Vk_20210730_04 |
|
|
04.08.2021 |
SEBIA |
CAPI 3 IMMUNOTYPING |
IVD: Immunotyping |
Vk_20210729_02 |
|
|
12.05.2021 (Updated 04.08.2021) |
RaySearch Laboratories AB (publ) |
RayStation |
MD: Radiation therapy software |
Vk_20210510_35 |
|
|
08.10.2019 (Updated 04.08.2021) |
Elekta, Inc. |
Monaco RTP System |
MD: Radiation therapy software |
Vk_20191001_12 |
|
|
03.08.2021 |
Respironics, Inc |
Trilogy Evo Trilogy Evo O2 Trilogy EV300 |
MD: Portable electric ventilator MD: Portable electric ventilator MD: Portable electric ventilator |
Vk_20210803_11 |
|
|
03.08.2021 |
Biocompatibles UK Ltd. (a subsidiary of Boston Scientific Corporation) |
TheraSphere Administration Sets |
AIMD: Manual-afterloading brachytherapy system source delivery procedure kit |
Vk_20210730_05 |
|
|
27.07.2021 (Updated 03.08.2021) |
Normand-Info S.A.S.U subsidiary of Beckman Coulter International S.A. |
Remisol Advance |
IVD: Clinical laboratory information system application software |
Vk_20210727_02 |
|
|
03.08.2021 |
William A. Cook Australia Pty Ltd |
MINC MINI INCUBATOR |
MD: Carbon dioxide laboratory incubator |
Vk_20210723_20 |
|
|
27.07.2021 (Updated 03.08.2021) |
BD Switzerland Sàrl |
SmartSite Needle Free Valve |
MD: Negative-Pressure Needleless Valve Connector, Extension sets & gravity sets, Intravenous Fluid Bag Spike, Electric infusion pump administration set, single-use |
Vk_20210629_13 |
|
|
02.06.2021 (Updated 03.08.2021) |
bioMérieux SA |
VIDAS Anti-HBs Total II |
IVD: Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) |
Vk_20210528_12 |
|
|
02.08.2021 |
Micro Therapeutics, Inc. |
Pipeline Flex Embolization Device & Pipeline Flex with Shield Technology |
MD: Bare-metal intracranial vascular stent |
Vk_20210722_24 |
|
|
26.07.2021 (Updated 02.08.2021) |
Roche Diabetes Care GmbH |
Accu-Chek Aviva, Performa and Inform II test strip |
IVD: Glucose IVD, reagent |
DE-1_DIST |
Vk_20210720_16 |
|
02.08.2021 |
Edwards Lifesciences LLC |
PediaSat Oximetry Catheter |
MD: Oximeter catheter, single-use |
Vk_20210716_25 |
|
|
23.06.2021 (Updated 02.08.2021) |
HeartWare Inc. |
HeartWare Ventricular Assist System (HVAD) |
AIMD: Implantable ventricular circulatory assist system |
Vk_20210603_18 |
|
|
29.07.2021 |
PROCEPT BioRobotics Corporation |
AQUABEAM Handpiece |
MD: Water jet knife system handpiece, single-use |
Vk_20210721_22 |
|
|
27.07.2021 (Updated 28.07.2021) |
Cordis Cashel |
SABER PTA Dilatation Catheter |
MD: Peripheral angioplasty balloon catheter, basic |
Vk_20210727_01 |
|
|
27.07.2021 |
Wassenburg Medical B.V. |
WASSENBURG WD4200 washer-disinfector |
MD: Endoscope washer/disinfector |
Vk_20210723_05 |
|
|
27.07.2021 (Updated 27.07.2021) |
Ethicon Endo-Surgery LLC |
Harmonic HD 1000i Shears |
MD: Soft-tissue ultrasonic surgical system handpiece tip, single-use |
Vk_20210719_28 |
|
|
20.07.2021 (Updated 27.07.2021) |
DiaMed GmbH |
NA |
IVD: Column agglutination IVD |
Vk_20210716_01 |
|
|
27.07.2021 |
W. L. Gore & Associates |
GORE Molding and Occlusion Balloon Catheter |
MD: Peripheral angioplasty balloon catheter, basic |
Vk_20210712_30 |
|
|
26.07.2021 |
Stryker Medical |
LIFEPAK 15 KEYPAD ASSY-MAIN CONTROL |
MD: LIFEPAK 15 Keypad |
Vk_20210721_21 |
|
|
01.06.2021 (Updated 26.07.2021) |
ADRIA S.R.L. |
B. Needle Vertebroplasty Kit of Cement Injection cannulas |
MD: Needles for biopsy MD: Vertebroplasty needles for the infusion of cements MD: Kit of Cement Injection cannulas for kyphoplasty |
Vk_20210527_16 |
|
|
20.07.2021 (Updated 23.07.2021) |
Olympus Medical Systems Corp. |
GASTROINTESTINAL VIDEOSCOPE GIF-EZ1500 COLONOVIDEOSCOPE CF-EZ1500DI COLONOVIDEOSCOPE CF-EZ1500DL EVIS X1 VIDEO SYSTEM CENTER CV-1500 |
MD: Flexible video gastroduodenoscope MD: Flexible video colonoscope, reusable MD: Flexible video colonoscope, reusable MD: Endoscopic video image processing/light source system |
Vk_20210716_24 |
|
|
21.07.2021 (Updated 23.07.2021) |
Suzhou Yuno Biotechnology Co. Ltd; Tai Zhou Sun Trine Biotechnology Co. |
Viral Transport Medium Tube - Saliva sample collector |
IVD: Sampling Kits |
DE-1-Suzho Yuno |
Vk_20210707_07 |
|
15.04.2020 (Updated 23.07.2021) |
Elekta, Inc. |
Monaco RTP System |
MD: Radiation therapy software |
Vk_20200407_09 |
|
|
28.11.2019 (Updated 23.07.2021) |
Elekta, Inc. |
Monaco RTP System |
MD: Radiation therapy software |
Vk_20191120_17 |
|
|
20.07.2021 (Updated 22.07.2021) |
Teleflex Medical SND BHD |
Endotracheal Tube - with cuff - Murphy - Sterile pack Flexiset SUPER SAFETY CLEAR TRACHEALTUBUS Ruschelit Safety Clear Plus Tracheal Tube, oral/nasal, cuffed Flexi-Set Cuffed Endotracheal Tube and Stylet Set and Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal |
MD: Basic endotracheal tube, single-use MD: Basic endotracheal tube, single-use MD: Basic endotracheal tube, single-use MD: Artificial airway stylet, single-use |
Vk_20210719_27 |
|
|
20.07.2021 (Updated 22.07.2021) |
Teleflex Malaysia |
PERCUQUICK ONE-STEP SET, PDT PERCUQUICK ONE-STEP DILATOR |
MD: Tracheostomy kit, single-use MD: Tracheostomy kit, single-use |
Vk_20210719_12 |
|
|
13.07.2021 (Updated 22.07.2021) |
Gyrus ACMI Inc. |
SOLTIVE PREMIUM LASER & SOLTIVE PRO LASER |
MD: The Soltive Laser is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery. |
Vk_20210708_16 |
|
|
08.06.2021 (Updated 22.07.2021) |
Smith & Nephew Medical Ltd. |
JELONET |
MD: Wound-nonadherent dressing, permeable, non-antimicrobial |
Vk_20210602_06 |
|
|
21.07.2021 |
B. Braun Melsungen AG |
Combitrans Monitoring Set with Hämofix reservoir |
MD: General/plastic surgical procedure kit, non-medicated, single-use |
Vk_20210713_20 |
|
|
20.07.2021 |
GE Healthcare |
Centricity Critical Care |
MD: Patient health record information system |
Vk_20210719_29 |
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20.07.2021 |
Respironics California, LLC |
V60 Ventilator V60 Plus Ventilator |
MD: Portable electric ventilator MD: Portable electric ventilator |
Vk_20210715_02 |
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20.07.2021 |
Apollo Endosurgery Inc |
Orbera Intragastric Balloon System BIB Intragastric Balloon System Orbera365 Intragastric Balloon System |
MD: Appetite-suppression gastric balloon MD: Appetite-suppression gastric balloon MD: Appetite-suppression gastric balloon |
Vk_20210714_07 |
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05.05.2021 (Updated 20.07.2021) |
N.G.C. Medical srl |
Prontopac PERICARDIOCENTESIS KIT |
MD: General/plastic surgical procedure kit, non-medicated, single-use MD: Pericardiocentesis catheter |
Vk_20210426_23 |
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19.07.2021 |
Schwarzer Cardiotek GmbH |
Evolution core |
MD: Cardiac catheterization laboratory computer |
Vk_20210712_37 |
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19.07.2021 |
Philips Goldway (Shenzhen) Industrial Inc. |
HeartStart Intrepid Monitor/Defibrillator |
MD: Rechargeable professional automated external defibrillator |
Vk_20210702_20 |
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19.07.2021 |
CooperSurgical Inc. |
Oxygen Sensors |
MD: Oxygen electrode |
Vk_20210701_12 |
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29.03.2021 (Updated 19.07.2021) |
Medtronic Inc. |
Activa Clinician Programmer Application |
AIMD: Multiple active implantable device programmer |
Vk_20210310_25 |
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07.04.2021 (Updated 18.07.2021) |
Radiometer Medical ApS |
ABL90 FLEX ABL90 FLEX PLUS |
IVD: Metabolic profile clinical chemistry analyser IVD, portable, automated IVD: Metabolic profile clinical chemistry analyser IVD, portable, automated |
Vk_20210331_12 |
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11.12.2020 (Updated 15.07.2021) |
Cardiac Pacemaker Inc |
EMBLEM S-ICD Subcutaneous Electrode (Lead) |
AIMD: Endocardial defibrillation lead |
Vk_20201203_08 |
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14.07.2021 |
Thommen Medical AG |
VARIOflex abutment set for crown |
MD: Dental implant suprastructure kit |
Vk_20210708_08 |
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13.07.2021 |
Merit Medical Systems, Inc. |
basixALPHA(TM) |
MD: Catheter/overtube balloon inflator, single-use |
Vk_20210709_15 |
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13.07.2021 |
Medtronic Inc. |
Vectris SureScan Lead Kit |
AIMD: Neural-tissue electrical stimulation lead |
Vk_20210708_10 |
|
|
13.07.2021 |
Illumina, Inc |
VeriSeq NIPT Solution v2 |
IVD: Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT) |
Vk_20210708_02 |
|
|
13.07.2021 |
GE / OEC Medical Systems Inc. |
OEC Elite OEC 3D |
MD: Mobile general-purpose fluoroscopic x-ray system, digital MD: Mobile general-purpose fluoroscopic x-ray system, digital |
Vk_20210706_21 |
|
|
13.07.2021 |
GE Healthcare |
SIGNA PET/MR SIGNA Pioneer, SIGNA Premier SIGNA Voyager Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T, SIGNA Architect, SIGNA Artist 1.5T Signa HDxt, SIGNA Creator, SIGNA Explorer |
MD: PET/MRI system MD: Full-body MRI system, superconducting magnet MD: Full-body MRI system, superconducting magnet MD: Full-body MRI system, superconducting magnet MD: Full-body MRI system, superconducting magnet |
Vk_20210702_19 |
|
|
12.07.2021 |
TORNIER SAS |
Inspyre Interpositional Shoulder Implant |
MD: Stem-fixed humeral head prosthesis |
Vk_20210621_02 |
|
|
12.07.2021 |
Arcoma AB |
Precision |
MD: Stationary basic diagnostic x-ray system, digital |
Vk_20210616_09 |
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|
29.06.2021 (Updated 09.07.2021) |
Roche Diagnostics GmbH |
cobas u pack |
IVD: Multiple urine analyte IVD, kit, colorimetric dipstick, rapid |
Vk_20210623_22 |
|
|
09.07.2021 |
TORNIER SAS |
Aequalis Pyrocarbon Humeral Head |
MD: Stem-fixed humeral head prosthesis |
Vk_20210621_01 |
|
|
08.07.2021 |
B. Braun Melsungen AG |
Combidyn Druckschlauch PE 120 CM, TRANSPARENT |
MD: Invasive blood pressure monitoring tubing set |
Vk_20210705_02 |
|
|
08.07.2021 |
Baxter Healthcare SA |
EASYGRIP FLO-41 Precision MIS Delivery System |
MD: Haematological concentrate system applicator, endoscopic |
Vk_20210621_05 |
|
|
07.07.2021 |
Pall Medical - A Division of Pall International Sàrl |
Pall Nanodyne ELD Filter Pall Lipipor TNA-Filter |
MD: Intravenous line filter MD: Intravenous line filter |
Vk_20210705_01 |
|
|
07.07.2021 |
Angiomed GmbH & Co. Medizintechnik KG |
Gastrotop Bile Endoprosthesis Set High Flex Basket Ecoflex Basket |
MD: Bile duct prosthesis MD: Biliary/urinary stone retrieval basket, single-use MD: Biliary/urinary stone retrieval basket, single-use |
Vk_20210630_21 |
|
|
05.07.2021 (Updated 07.07.2021) |
Beckman Coulter , Inc. |
Kaluza C Software |
IVD: Laboratory instrument/analyser application software IVD |
Vk_20210628_22 |
|
|
06.07.2021 |
Siemens AG Healthcare |
Artis zee/Q/Q.zen systems |
MD: Stationary angiographic x-ray system, digital |
Vk_20210705_21 |
|
|
06.07.2021 |
Mentor Medical Systems B.V. |
Siltex Round High Profile |
MD: Silicone gel-filled breast implant |
Vk_20210702_23 |
|
|
06.07.2021 |
GE Medical Systems Information Technologies, Inc. |
Patient Data Module |
MD: Patient monitoring system module, multifunction |
Vk_20210629_10 |
|
|
06.07.2021 |
NVT GmbH |
ALLEGRA Delivery System TF |
MD: Transcatheter heart valve bioprosthesis implantation catheter |
Vk_20210629_01 |
|
|
05.07.2021 |
Meyra GmbH + Co |
Scooter CL409/CL510 |
MD: Scooters, Powered |
Vk_20210625_15 |
|
|
05.07.2021 |
SONY Corporation |
SONY LMD-1951MD MONITORS |
MD: Image display monitor, colour |
Vk_20210623_06 |
|
|
30.06.2021 (Updated 02.07.2021) |
bioMérieux SA |
ETEST IMIPENEM RELEBACTAM |
IVD: Antibacterial minimum inhibitory concentration (MIC) IVD |
Vk_20210628_27 |
|
|
02.07.2021 (Updated 02.07.2021) |
Sengewald Klinikprodukte GmbH |
Custom Procedure Trays containing syringes and needles from BD |
MD: Infusion And Irrigation Syringes, 2-piece Luer Cone, Single-use |
Vk_20210617_19 |
|
|
14.06.2021 (Updated 02.07.2021) |
Medtronic Inc. |
Deep Brain Stimulation (DBS) Lead Kits Stimloc Spares Kit Stimloc Burr Hole Cover StimLoc Support Clips |
AIMD: Deep brain electrical stimulation system AIMD: Craniofacial fixation plate, non-bioabsorbable AIMD: Deep brain electrical stimulation system AIMD: Deep brain electrical stimulation system |
Vk_20210602_15 |
|
|
01.07.2021 |
W. L. Gore & Associates |
GORE PROPATEN Vascular Graft |
MD: Synthetic vascular graft |
Vk_20210628_07 |
|
|
01.06.2021 (Updated 01.07.2021) |
Roche Diagnostics GmbH |
cobas 6500 urine analyzer series cobas u 701 microscopy analyzer |
IVD: Urine analyser IVD, laboratory, automated IVD: Urine analyser IVD, laboratory, automated |
Vk_20210527_28 |