Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2021 – 31.03.2021
Опубліковано 02.04.2021 о 17:11https://fsca.swissmedic.ch/mep/#/
06.04.2021 |
SERF |
Jauges broche F.A.S.T. |
MD: Orthopaedic prosthesis implantation instrument, reusable |
Vk_20210331_03 |
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06.04.2021 |
Medtronic Inc. |
Intellis Recharger |
AIMD: Noninvasive device battery charger |
Vk_20210325_12 |
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06.04.2021 |
Covidien LLC |
Surgiwand II Auto Suture Suction and Irrigation Device |
MD: Surgical irrigation/aspiration cannula, non-illuminating, single-use |
Vk_20210322_07 |
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06.04.2021 |
EUROIMMUN Medizinische Labordiagnostika AG |
EUROLINE sample buffer |
IVD: Sample buffer |
Vk_20210309_16 |
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02.12.2020 (Updated 06.04.2021) |
Hitachi High Technologies Corporation (HHT) |
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 |
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01.04.2021 |
Medline International France SAS |
Medline Sterile Procedure Trays |
MD: Syringe |
Vk_20210326_10 |
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31.03.2021 |
Greiner Bio-One GmbH |
VACUETTE 9NC Coagulation Tube |
IVD: Coagulation Tube |
Vk_20210329_06 |
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31.03.2021 |
CareDx AB |
SCORE 6 |
IVD: Human genomic analysis interpretive software |
Vk_20210325_03 |
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31.03.2021 |
Arcoma AB |
Intuition |
MD: Stationary basic diagnostic x-ray system, digital |
Vk_20210322_26 |
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23.03.2021 (Updated 31.03.2021) |
Ortho Clinical Diagnostics |
ORTHO VISION Analyser ORTHO VISION Max Analyzer |
IVD: Blood group/antibody screening analyser IVD, automated IVD: Blood group/antibody screening analyser IVD, automated |
Vk_20210317_25 |
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31.03.2021 |
Sirona Dental Systems GmbH |
INTEGO |
MD: Dental delivery unit |
Vk_20210317_01 |
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16.03.2021 (Updated 31.03.2021) |
Clerio Vision |
Extreme H20 59 Xtra |
MD: Contact lens |
Vk_20210315_02 |
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20.02.2020 (Updated 31.03.2021) |
Siemens Healthcare Diagnostics Inc |
Atellica CH Ethyl Alcohol (ETOH) |
IVD: Ethanol (ETOH) IVD, kit, enzyme spectrophotometry |
Vk_20200217_18 |
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30.03.2021 |
Omnia Srl |
Soft Tissue Punch |
MD: Dental soft-tissue coring punch, single-use |
Vk_20210326_18 |
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18.03.2021 (Updated 30.03.2021) |
Covidien llc |
Kangaroo Enteral Feeding Non-Sterile Pump Sets |
MD: Enteral feeding noninvasive-component set |
Vk_20210304_25 |
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29.03.2021 |
B. Braun Medical AG |
proSA Valve and proSA Shuntsystem |
AIMD: Ventriculo-peritoneal/atrial shunt valve |
Vk_20210326_01 |
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23.03.2021 (Updated 29.03.2021) |
Roche Molecular Systems Inc. |
cobas SARS-CoV-2 & Influenza A/B cobas Liat Analyzer |
IVD: Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) IVD: Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated |
Vk_20210322_30 |
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18.03.2021 (Updated 29.03.2021) |
bioMerieux Inc |
VIDAS CMV IGM 30 TESTS |
IVD: Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) |
Vk_20210318_11 |
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23.03.2021 (Updated 26.03.2021) |
Beckman Coulter , Inc. |
Access Progesterone DE Calibrators |
IVD: Progesterone IVD, kit, chemiluminescent immunoassay |
Vk_20210319_22 |
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26.03.2021 |
Christoph Miethke GmbH & Co. KG |
SPRUNG RESERVOIR |
MD: Cerebrospinal fluid reservoir |
Vk_20210319_18 |
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23.03.2021 (Updated 26.03.2021) |
Hologic, Inc. |
Panther Fusion Tube Tray |
IVD: Tube Tray |
Vk_20210318_12 |
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16.03.2021 (Updated 26.03.2021) |
Medtronic Minimed |
MiniMed 780G Insulin Pump |
MD: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm |
Vk_20210316_01 |
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25.03.2021 |
Amplitude S.A.S. |
UNI SCORE tibial tray for fixed bearing insert |
MD: Uncoated unicondylar knee tibia prosthesis, metallic |
Vk_20210317_23 |
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17.02.2021 (Updated 25.03.2021) |
Bovie Medical Corporation |
Disposable Bipolar Ablators |
MD: Electrosurgical system |
Vk_20210205_04 |
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24.03.2021 |
Siemens Healthcare Diagnostics Inc |
ADVIA Chemistry Systems |
IVD: Clinical chemistry analyser |
Vk_20210322_29 |
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24.03.2021 |
Beaver Visitec International Ltd |
BVI CustomEyes Kits and Malosa Kits |
MD: Ophthalmic surgical procedure kit, non-medicated, single-use |
Vk_20210211_06 |
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23.03.2021 (Updated 23.03.2021) |
Siemens Healthcare GmbH, Magnetic Resonance (MR) |
ARTIS pheno systems Artis icono |
MD: Stationary angiographic x-ray system, digital MD: Stationary angiographic x-ray system, digital |
Vk_20210322_12 |
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23.03.2021 |
Radiometer Medical ApS |
PICO70 |
MD: Arterial blood sampling kit |
Vk_20210319_02 |
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23.03.2021 |
TRANSMED MEDIZINTECHNIK GMBH & CO. KG |
Transfusionsgerät 200µm |
MD: Blood transfusion set, non-exchange |
Vk_20210319_01 |
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23.03.2021 |
Boston Scientific Corporation |
Mamba 135 Mamba Flex 135 |
MD: Vascular microcatheter MD: Vascular microcatheter |
Vk_20210316_12 |
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22.03.2021 |
BIOSPEEDIA International SARL |
BioSpeedia COVID19 Speed-Antigen Test |
IVD: SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid |
Vk_20210318_09 |
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16.03.2021 (Updated 22.03.2021) |
Abbott |
Assurity Endurity |
AIMD: Dual-chamber implantable pacemaker, rate-responsive AIMD: Single-chamber implantable pacemaker, rate-responsive |
Vk_20210315_25 |
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16.03.2021 (Updated 22.03.2021) |
Philips Medical Systems |
HeartStart FR2+ Philips HeartStart FRx AED HeartStart HS1 |
MD: Automatic external defibrillator MD: Non-rechargeable public automated external defibrillator MD: Defibrillator, automated, external |
Vk_20210312_16 |
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17.03.2021 (Updated 22.03.2021) |
Siemens Healthcare Diagnostics Inc |
ADVIA 2120/2120i Hematology System |
IVD: Haematological cell analyser IVD, automated |
Vk_20210309_17 |
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22.03.2021 |
Siemens AG Healthcare |
Sensis |
MD: Cardiac catheterization laboratory computer |
Vk_20210304_10 |
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09.03.2021 (Updated 18.03.2021) |
DePuy Ireland |
MBT CEM KEEL TIB TRAY ATTUNE FB TIB BASE SZ |
MD: Uncoated knee tibia prosthesis, metallic MD: Uncoated knee tibia prosthesis, metallic |
Vk_20210226_26 |
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02.03.2021 (Updated 18.03.2021) |
Biosense Webster Inc |
CARTO Vizigo Bi-Directional Guiding Sheath |
MD: Vascular guide-catheter, single-use |
Vk_20210224_19 |
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05.02.2021 (Updated 18.03.2021) |
NuVasive Specialized Orthopedics, Inc., a division of NuVasive, Inc. |
PRECICE System |
MD: Long bone distraction rod, magnetic |
Vk_20210202_09 |
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17.03.2021 (Updated 17.03.2021) |
Siemens Healthcare Diagnostics Products GmbH |
BCS XP System |
IVD: Coagulation analyser IVD, laboratory, automated |
Vk_20210304_06 |
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17.03.2021 |
RECIPE Chemicals + Instruments GmbH |
ClinCal Whole Blood Calibrator Immunosuppressants |
IVD: Calibrators Multicomponent (CC) |
Vk_20210302_25 |
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09.03.2021 (Updated 15.03.2021) |
HeartWare Inc. |
HeartWare Ventricular Assist System – HVAD Pump Implant Kit |
AIMD: Implantable ventricular circulatory assist system |
Vk_20210305_06 |
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09.03.2021 (Updated 15.03.2021) |
Siemens Healthcare GmbH, Diagnostic Imaging, X-Ray-Products |
YSIO X.pree |
MD: Stationary basic diagnostic x-ray system, digital |
Vk_20210304_12 |
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12.03.2021 |
Caire Diagnostics |
Fenom Pro Asthma Monitor |
IVD: Nitrogen monoxide analyser |
Vk_20210305_08 |
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12.03.2021 |
BD Switzerland Sàrl |
Infusion sets for Alaris pump Gravity Infusion Sets and Connectors (various) |
MD: syringe / volumetric pump infusion sets MD: Gravity sets, needle-free connectors and Accessories |
Vk_20210302_06 |
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03.03.2021 (Updated 12.03.2021) |
RaySearch Laboratories AB |
Radiation therapy treatment planning software |
MD: Radiation therapy treatment planning system |
Vk_20210224_12 |
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10.03.2021 (Updated 11.03.2021) |
Weinmann Emergency Medical Technology GmbH + Co. KG |
Medumat Transport |
MD: Transport electric ventilator |
Vk_20210308_09 |
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09.03.2021 (Updated 11.03.2021) |
UmanDiagnostics AB |
NF-light ELISA |
IVD: Neurofilament protein IVD, kit, enzyme immunoassay (EIA) |
Vk_20210303_03 |
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29.12.2020 (Updated 11.03.2021) |
DePuy Ireland |
PINNACLE 100 ACET CUP PINNACLE 100 HA ACET CUP PINN SECTOR HA ACET CUP PINN SECTOR ACET CUP PINN 100 W/GRIPTION PINN SECTOR W/GRIPTION |
MD: Acetabular shell MD: Acetabular shell MD: Acetabular shell MD: Acetabular shell MD: Acetabular shell MD: Acetabular shell |
Vk_20201223_11 |
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10.03.2021 |
Accuray Incorporated (Madison) |
CyberKnife |
MD: Linear accelerator system |
Vk_20210308_10 |
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10.03.2021 |
Biotronik SE & Co. KG |
Idova, Iforia, Ilesto, Inventra, Iperia, Itrevia, Ilivia, Inlexa, Intica, Ilivia Neo, Intica Neo ICDs and CRT-Ds |
AIMD: Defibrillator, implantable |
Vk_20210303_21 |
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10.03.2021 |
Asid Bonz GmbH |
Urosid Basic Silicon |
MD: Catheters, Urinary, Urethral, Drainage, Self-Retained |
Vk_20210302_27 |
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17.02.2021 (Updated 10.03.2021) |
Getinge – Maquet GmbH |
MAGNUS Table Column |
MD: Electrohydraulic operating table base |
Vk_20210212_02 |
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09.03.2021 |
Nutricia Medical Devices BV |
Flocare Infinity Enteral feeding pump Flocare Infinity Enteral feeding pump |
MD: Enteral feeding pump MD: Enteral feeding pump |
Vk_20210308_04 |
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09.03.2021 |
Life Technologies Corporation, a part of Thermo Fisher Scientific |
Applied Biosystems COVID-19 Interpretive Software |
IVD: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) |
Vk_20210303_20 |
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02.03.2021 (Updated 09.03.2021) |
Riverside Medical Packaging Company Ltd |
Aseptic Medical Devices |
MD: Medication transfer set |
Vk_20210224_23 |
|
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08.03.2021 |
Aesculap AG |
AESCULAP Univation X System |
MD: Unicondylar knee insert |
Vk_20210308_13 |
|
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24.02.2021 (Updated 05.03.2021) |
Siemens Healthcare GmbH |
Artis Q / Q.zen / pheno / icono |
MD: Stationary angiographic x-ray system, digital |
Vk_20210217_11 |
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22.04.2020 (Updated 05.03.2021) |
HeartWare Inc. |
HeartWare Ventricular Assist System – HVAD Pump Implant Kit |
AIMD: Implantable ventricular circulatory assist system |
Vk_20200408_03 |
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04.03.2021 |
Neuromedex GmbH |
MEDILOOPS |
MD: Tapes |
Vk_20210226_10 |
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04.03.2021 |
Siemens Medical Solutions USA, Inc., Ultrasound |
Acuson Sequoia, Diagnostic Ultrasound |
MD: Scanner, ultrasonic, general-purpose |
Vk_20210217_13 |
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04.03.2021 |
Mercado Medic AB |
REAL 9000 REAL 6100 REAL 2000 |
MD: Assistive ergonomic chair MD: Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, non-collapsible MD: Assistive ergonomic chair |
Vk_20210211_16 |
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03.03.2021 |
bioMerieux SA |
VIDAS CMV IGM 30 TESTS |
IVD: Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) |
Vk_20210226_25 |
|
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03.03.2021 |
Caesarea Medical Electronics Limited |
Bodyguard 121 Twins |
MD: Multichannel general-purpose infusion pump |
Vk_20210223_14 |
|
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02.03.2021 |
Teleflex Malaysia |
Tracflex Plus PDT Tracflex Plus Tracheostomy Tube Set |
MD: Tracheostomy kit, single-use MD: Tracheostomy tube, non-reinforced, non-customized, single-use |
Vk_20210301_15 |
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02.03.2021 |
Bolton Medical Inc. |
RelayPlus Relay 85 |
MD: Descending thoracic aorta endovascular stent-graft MD: Descending thoracic aorta endovascular stent-graft |
Vk_20210225_03 |
|
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02.03.2021 |
Biomet France |
T.E.S.S. (Total Evolutive Shoulder System) |
MD: Total shoulder prosthesis |
Vk_20210218_15 |
|
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24.02.2021 (Updated 02.03.2021) |
Physio-Control Corporation |
LIFEPAK CR2 defibrillator |
MD: Non-rechargeable public semi-automated external defibrillator |
Vk_20210218_01 |
|
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16.02.2021 (Updated 02.03.2021) |
Olympus Medical Systems Corp. |
OLYMPUS EVIS LUCERA ELITE DUODENOVIDEOSCOPE OLYMPUS EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS DUODENOVIDEOSCOPE SINGLE USE DISTAL COVER |
MD: Flexible video duodenoscope, reusable MD: Flexible video duodenoscope, reusable MD: Flexible video duodenoscope, reusable MD: Flexible video duodenoscope, reusable |
Vk_20210211_25 |
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26.11.2020 (Updated 02.03.2021) |
Cardinal Health |
Protexis Latex Micro Surgical Gloves |
MD: Hevea-latex surgical glove, non-powdered, non-antimicrobial |
Vk_20201023_03 |
|
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22.10.2020 (Updated 02.03.2021) |
B.BRAUN MEDICAL |
Actreen Hi-Lite Cath Nelaton Actreen Glys Set Nelaton Actreen Mini Cath Nelaton Urinocol Pädiatrie Girl geschlossen Actreen Lite Cath |
MD: Urine-sampling urethral catheter MD: Urine-sampling urethral catheter MD: Urine-sampling urethral catheter MD: Enteral feeding tube clearing kit MD: Urine-sampling urethral catheter |
Vk_20201012_15 |
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22.02.2021 (Updated 01.03.2021) |
CARAG AG |
Carag Bioresorbable Septal Occluder (CBSO) System |
MD: Cardiac occluder |
Vk_20210218_09 |
|
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01.03.2021 |
Dent4You AG |
DE Single Bond 7th Generation |
MD: Dentine bonding agent/set |
Vk_20210215_19 |
|
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01.03.2021 |
Schiller AG |
Fred easy |
MD: Semi-automated external defibrillator |
Vk_20210215_12 |
|
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24.11.2020 (Updated 01.03.2021) |
Karl Storz Endoskope SE und Co. KG |
HYSTEROMAT E.A.S.I. SCB |
MD: Surgical irrigation/aspiration system |
Vk_20201123_08 |
|
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23.02.2021 (Updated 26.02.2021) |
B. Braun Melsungen AG |
Application Kit for subc. Admin. |
MD: Needle |
Vk_20210222_02 |
|
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25.02.2021 |
Merit Medical Systems, Inc. |
HeartSpan(R) Transseptal Needle |
MD: Cardiac transseptal needle, single-use |
Vk_20210204_03 |
|
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06.10.2020 (Updated 25.02.2021) |
ACUTRONIC Medical Systems AG |
fabian +nCPAP evolution Fabian HFO |
MD: Neonatal intensive-care ventilator MD: Neonatal intensive-care ventilator |
Vk_20201001_05 |
|
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09.02.2021 (Updated 24.02.2021) |
Cardiac Pacemaker Inc |
4G LATITUDE MIMIC Cell Adapter |
: Adapter |
Vk_20210204_13 |
|
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23.02.2021 |
BD Medical |
Becton Dickinson Syringes |
MD: Metered-delivery hypodermic syringe |
Vk_20210222_28 |
|
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23.02.2021 |
Leica Biosystems Newcastle Ltd |
BOND Ready-to-Use Primary Antibody CD19 (BT51E) Novocastra Liquid Mouse Monoclonal Antibody CD19 |
IVD: CD19 antibody IVD: CD19 antibody |
Vk_20210218_16 |
|
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23.02.2021 |
Cordis Corporation |
PRECISE PRO RX Carotid Stent System |
MD: Bare-metal carotid artery stent |
Vk_20210217_01 |
|
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17.02.2021 (Updated 22.02.2021) |
Abbott |
Alinity i HIV Ag/Ab Combo Calibrator |
IVD: HIV1/HIV2 antigen/antibody IVD, calibrator |
Vk_20210211_04 |
|
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09.02.2021 (Updated 22.02.2021) |
Microbiologics, Inc. |
KWIK-STIK 0947P-K-LYFO-DISK_QC Sets&Panels 5193P |
IVD: Multiple-type bloodstream pathogen nucleic acid IVD, control |
Vk_20210208_09 |
|
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22.02.2021 |
Haemonetics Corporation |
Blood donor set, quad-pack Blood transfusion filter |
MD: Blood donor set, quad-pack MD: Blood transfusion filter |
Vk_20210205_02 |
|
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18.02.2021 (Updated 22.02.2021) |
iMDsoft Ltd |
MetaVision Suite |
MD: Information system |
Vk_20210203_21 |
|
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17.02.2021 (Updated 19.02.2021) |
Siemens Healthcare GmbH |
Sensis, Sensis Vibe Combo, Sensis Vibe Hemo |
MD: Cardiac catheterization laboratory computer |
Vk_20210210_22 |
|
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10.02.2021 (Updated 18.02.2021) |
MAQUET Cardiopulmonary GmbH |
Heater-Cooler Unit HCU 40 High Voltage |
MD: Cardiopulmonary bypass system heat exchanger, reusable |
Vk_20210208_01 |
|
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09.02.2021 (Updated 17.02.2021) |
Medtronic Inc. |
Claria MRI / Amplia MRI / Compia MRI / Viva / Brava CRT-Ds Visia AF / Visia AF MRI / Evera / Evera MRI ICDs |
AIMD: Cardiac resynchronization therapy implantable defibrillator AIMD: Single-chamber / Dual-chamber implantable defibrillator |
Vk_20210203_07 |
|
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16.02.2021 |
The Binding Site Group Limited |
Diphtheria Toxoid IgG Enzyme Immunoassay Kit |
IVD: Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
Vk_20210216_02 |
|
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16.02.2021 |
Lohmann & Rauscher GmbH & Co. KG |
Ophthalmological Kitpack / Raucoset |
MD: Ophthalmic surgical procedure kit, non-medicated, single-use |
Vk_20210215_18 |
|
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16.02.2021 |
Lohmann & Rauscher GmbH & Co. KG |
Ophthalmological Kitpack |
MD: Ophthalmic surgical procedure kit, non-medicated, single-use |
Vk_20210215_17 |
|
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16.02.2021 |
XENIOS AG |
DELTASTREAM Systemwagen III MDC |
MD: deltastream trolley |
Vk_20210215_15 |
|
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16.02.2021 |
Miltenyi Biotec GmbH |
Blood/tissue storage/culture Container |
MD: Blood/tissue storage/culture container |
Vk_20210211_26 |
|
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16.02.2021 |
MicroVention Europe S.A.R.L. |
PHIL – Liquid Embolic |
MD: Neurovascular embolization plug |
Vk_20210211_03 |
|
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16.02.2021 |
Weinmann Emergency Medical Technology GmbH + Co. KG |
Medumat Transport |
MD: Transport electric ventilator |
Vk_20210211_02 |
|
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16.02.2021 |
Intersurgical Ltd |
CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MA |
MD: Nebulizing system delivery set, single-use |
Vk_20201222_18 |
|
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11.02.2021 (Updated 15.02.2021) |
Steripack SA |
Syringes with Sodium Chloride 0.9% |
MD: Sterile saline flush syringe |
Vk_20210210_27 |
|
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11.02.2021 (Updated 15.02.2021) |
CareDx AB |
Olerup QTYPE 11 |
IVD: Tissue Typing Reagents |
Vk_20210202_02 |
|
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19.05.2020 (Updated 12.02.2021) |
Siemens Healthcare Diagnostics Inc. |
Atellica IM 1600 Atellica IM 1300 |
IVD: Chemiluminescent immunoassay analyser IVD, automated IVD: Chemiluminescent immunoassay analyser IVD, automated |
Vk_20200512_06 |
|
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10.02.2021 |
Microbiologics, Inc. |
KWIK-STIK 0318P & Comprehensive QC Sets 5190P |
IVD: Multiple-type bloodstream pathogen nucleic acid IVD, control |
Vk_20210208_11 |
|
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03.02.2021 (Updated 10.02.2021) |
Arkray Factory, Inc. |
SPOTCHEM D-00 QR SD-9811 SPOTCHEM D-00 SD-9810 |
IVD: Computer/medical device keyboard IVD: Computer/medical device keyboard |
Vk_20210129_12 |
|
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09.02.2021 |
Gambro Lundia AB Monitor Division |
Prismaflex |
MD: Haemodialysis system, institutional |
Vk_20210204_18 |
|
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09.02.2021 |
BD Medical |
BD Syringes and Needles |
MD: General-purpose syringe, single-use |
Vk_20210203_25 |
|
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03.02.2021 (Updated 09.02.2021) |
BioFire Diagnostics, LLC |
FilmArray Blood Culture Identification (BCID) Panel |
IVD: Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry |
Vk_20210127_20 |
|
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27.01.2021 (Updated 09.02.2021) |
Maquet Critical Care AB |
SoKINOX / SERViNO |
MD: Nitric oxide delivery unit, system-based |
Vk_20210120_28 |
|
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08.02.2021 |
C-A-T Resources |
C-A-T Combat Application Tourniquet |
MD: Tourniquets |
Vk_20210125_01 |
|
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03.02.2021 |
Siemens Healthcare Diagnostics Inc |
Dimension Vista High Density Lipoprotein Cholesterol Flex reagent cartridge |
IVD: High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry |
Vk_20210129_13 |
|
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03.02.2021 |
Mölnlycke Health Care AB |
Mölnlycke Procedure Trays and Single Packed Trocars |
MD: Surgical procedure kit and single packed Tocars |
Vk_20210125_17 |
|
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02.02.2021 |
Thermo Fisher Scientific Oy |
Cascadion SM Clinical Analyzer |
IVD: Liquid chromatography/mass spectrometry (LC/MS) analyser IVD, automated |
Vk_20210126_23 |
|
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02.02.2021 |
Rheon Medical SA |
eyeWatch implant |
MD: Glaucoma shunt |
Vk_20210120_18 |
|
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20.01.2021 (Updated 01.02.2021) |
Siemens Healthcare Diagnostics Inc. |
Atellica IM and ADVIA Centaur fPSA Calibrator |
IVD: Free (unbound) prostate specific antigen (fPSA) IVD, calibrator |
Vk_20210114_35 |
|
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20.01.2021 (Updated 29.01.2021) |
Philips Ultrasound Inc. |
EPIQ Ultrasound System |
MD: General-purpose ultrasound imaging system |
Vk_20210112_15 |
|
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28.01.2021 |
Solutions for tomorrow AB |
! M1mobile X-ray |
MD: Mobile basic diagnostic x-ray system, digital |
Vk_20210114_36 |
|
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27.07.2020 (Updated 28.01.2021) |
Lohmann & Rauscher GmbH & Co. KG |
Gauze swabs with x-ray thread in Kitpack, SetPack |
MD: Woven gauze pad, sterile |
DE-1-2 KIT |
Vk_20200721_04 |
|
|||||
10.06.2020 (Updated 28.01.2021) |
Siemens Healthcare Diagnostics Products Limited |
PRISCA Prenatal Risk Calculation Software |
IVD: Congenital defect/syndrome risk assessment interpretive software |
Vk_20200605_19 |
|
||||||
27.01.2021 |
Dräger Medical AG & Co. |
various: Dräger Neo disposable breathing systems |
MD: Tubing |
Vk_20210122_14 |
|
||||||
26.01.2021 |
Boston Scientific Corporation |
Captivator Captivator II Captiflex Sensation |
MD: Mechanical-cutting endoscopic polypectomy snare MD: Mechanical-cutting endoscopic polypectomy snare MD: Mechanical-cutting endoscopic polypectomy snare MD: Mechanical-cutting endoscopic polypectomy snare |
Vk_20210121_12 |
|
||||||
26.01.2021 |
ConvaTec Limited |
Aquacel Extra |
MD: Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial |
Vk_20210120_16 |
|
||||||
26.01.2021 |
Baxter Healthcare SA |
PrisMax, V2, ROW |
MD: Haemodialysis system, institutional |
Vk_20210118_25 |
|
||||||
19.01.2021 (Updated 25.01.2021) |
Medtronic Inc. |
Medtronic Strata II Delta and CSF-Flow Control Valves |
MD: Hydrocephalic shunt MD: Hydrocephalic shunt |
Vk_20210118_05 |
|
||||||
20.01.2021 (Updated 25.01.2021) |
Leonhard Lang GmbH |
Schiller Defibrillationselektrode |
MD: Electrodes, Cardiac, External Defibrillator |
Vk_20210114_23 |
|
||||||
24.12.2020 (Updated 22.01.2021) |
Bioventus, LLC |
EXOGEN Ultrasound Gel |
MD: Coupling gel, non-sterile |
Vk_20201221_07 |
|
||||||
22.12.2020 (Updated 22.01.2021) |
Likamed GmbH |
Selexa |
MD: Bed chair |
Vk_20201216_10 |
|
||||||
19.01.2021 (Updated 21.01.2021) |
Sartorius Stedim Biotech GmbH |
Minisart NML Minisart Ophthalsart |
MD: Laboratory syringe filter MD: Laboratory syringe filter |
Vk_20210115_06 |
|
||||||
21.01.2021 |
Terumo BCT, Inc. |
Spectra Optia Apheresis System |
MD: Apheresis system |
Vk_20210112_16 |
|
||||||
18.12.2020 (Updated 21.01.2021) |
Mathys Ltd Bettlach |
Affinis Inverse glenosphere vitamys Affinis Inverse glenosphere PE |
MD: Artificial shoulder joint MD: Artificial shoulder joint |
Vk_20201210_31 |
|
||||||
28.11.2019 (Updated 21.01.2021) |
Medtronic MiniMed |
Medtronic MiniMed 640G Insulin Pump MiniMed 670G Insulin Pump |
MD: Ambulatory insulin infusion pump, electronic MD: Ambulatory insulin infusion pump, electronic |
Vk_20191125_03 |
|
||||||
20.01.2021 |
Philips Ultrasound Inc. |
EPIQ Ultrasound System |
MD: General-purpose ultrasound imaging system |
Vk_20210118_22 |
|
||||||
20.01.2021 |
GE Medical Systems LLC |
Revolution CT |
MD: Full-body CT system |
Vk_20210114_34 |
|
||||||
19.01.2021 (Updated 20.01.2021) |
Nihon Kohden Corp. |
Multiple Patient Receiver |
MD: Electrocardiography telemetric monitoring system receiver |
Vk_20210114_28 |
|
||||||
19.01.2021 (Updated 20.01.2021) |
Olympus Medical Systems Corp. |
Various EndoTherapy products |
MD: Endotherapy device |
Vk_20210111_20 |
|
||||||
12.01.2021 (Updated 20.01.2021) |
Olympus Medical Systems Corp. |
GASTROINTESTINAL VIDEOSCOPE GIF-EZ1500 COLONOVIDEOSCOPE CF-EZ1500DI COLONOVIDEOSCOPE CF-EZ1500DL |
MD: Flexible video gastroduodenoscope MD: Flexible video gastroduodenoscope MD: Flexible video gastroduodenoscope |
Vk_20210108_17 |
|
||||||
19.01.2021 |
GE Medical Systems (China) Co., Ltd |
Vivid |
MD: Cardiovascular ultrasound imaging system |
Vk_20210114_45 |
|
||||||
19.01.2021 |
Voco GmbH |
Rebilda Post System Set Rebilda Post System Set II Rebilda Post Set |
MD: Root canal post, preformed MD: Root canal post, preformed MD: Root canal post, preformed |
Vk_20210114_32 |
|
||||||
17.11.2020 (Updated 15.01.2021) |
Respironics California, LLC |
V60 Ventilator V60 Plus Ventilator V680 Ventilator |
MD: Portable electric ventilator MD: Portable electric ventilator MD: General-purpose intensive-care ventilator |
Vk_20201112_10 |
|
||||||
07.01.2021 (Updated 14.01.2021) |
Invacare Corporation |
Invacare Perfecto2 V Oxygen Concentrator |
MD: Mobile/portable oxygen concentrator |
Vk_20201229_11 |
|
||||||
23.12.2020 (Updated 14.01.2021) |
Spacelabs Healthcare Ltd |
SENTINEL |
MD: Cardiology information system application software |
Vk_20201215_15 |
|
||||||
13.01.2021 |
Draeger Medical Systems, Inc. |
Infinity Acute Care System |
MD: General-purpose multi-parameter bedside monitor |
Vk_20210106_03 |
|
||||||
22.12.2020 (Updated 13.01.2021) |
MAQUET Cardiopulmonary GmbH |
Pediatric Venous Hardshell Cardiotomy Reservoir |
MD: Cardiotomy reservoir |
Vk_20201218_20 |
|
||||||
12.01.2021 |
Cook Incorporated |
Kwart Retro-Inject Ureteral Stent Set |
MD: Polymeric ureteral stent |
Vk_20210111_21 |
|
||||||
15.12.2020 (Updated 11.01.2021) |
Carl Zeiss Meditec AG |
IOLMaster 700 |
MD: Optical low coherence reflectometry (OLCR) biometer |
Vk_20201208_19 |
|
||||||
09.12.2020 (Updated 11.01.2021) |
Siemens Healthcare Diagnostics Inc |
Atellica IM 1300 Atellica CH 930 Analyzer Atellica IM 1600 |
IVD: Chemiluminescent immunoassay analyser IVD, automated IVD: Chemiluminescent immunoassay analyser IVD, automated IVD: Chemiluminescent immunoassay analyser IVD, automated |
Vk_20201207_15 |
|
||||||
29.09.2020 (Updated 11.01.2021) |
Siemens Healthcare Diagnostics Inc |
ADVIA Centaur HBsAgII |
IVD: Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay |
Vk_20200925_10 |
|
||||||
05.02.2020 (Updated 11.01.2021) |
Siemens Healthcare Diagnostics Inc. |
Atellica CH 930 Reaction Cuvette Segment |
IVD: Laboratory analyser cuvette IVD, reusable |
Vk_20200128_08 |
|
||||||
30.12.2020 (Updated 08.01.2021) |
Qiagen GmbH |
QIAstat-Dx Respiratory SARS-CoV-2 Panel |
IVD: Other Nucleic Acid Identification – automated |
Vk_20201230_01 |
|
||||||
24.12.2020 (Updated 08.01.2021) |
Liko AB |
Multirall 200 |
MD: Stationary patient lifting system, line-powered |
Vk_20201215_16 |
|
||||||
22.12.2020 (Updated 08.01.2021) |
BD |
BD 1ml Syringe Luer-Lok BD Blunt Fill Needle with Filter 18G x 1 1/2Model: 305211 BD Microlance 3 30G x 1/2 0, 3 x 13mmModel: 302809; 304000 |
MD: General-purpose syringe, single-useMD: Imaging lesion localization marker, external, reusableMD: Medication transfer needle, filtering MD: Hypodermic needle, single-use |
Vk_20201209_19 |
|
||||||
07.01.2021 |
WRP Asia Pacific |
Dermagrip Ellbogen-Handschuh |
MD: Hevea-latex surgical glove, non-powdered, non-antimicrobial |
Vk_20210105_08 |
|
||||||
07.01.2021 |
GE Medical Systems Israel, Functional Imaging |
Discovery NM 630, Optima NM/CT 640, Discovery NM/CT 670 DR, Discovery NM/CT 670 Pro, Discovery NM/CT 670ES, NM 830, NM 830 DoD, NM/CT 850, NM/CT 860, NM/CT 870 CZT, NM/CT 870 DR |
MD: Stationary gamma camera system |
Vk_2021010 |
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