Datum | Številka zadeve | Proizvajalec | Medicinski pripomoček |
---|---|---|---|
01.10.2021 | 301-226/2021 | Abbott Laboratories, ZDA | ARCHITECT c4000 Processing Module (2P24/1P86/1R24/1R25) ARCHITECT i2000 Processing Module (1G17/8C89) |
01.10.2021 | 301-227/2021 | Abbott Laboratories, ZDA | ARCHITECT i1000SR Processing Module (1L86/1L87) ARCHITECT i2000SR Processing Module (3M74) ARCHITECT c8000 Processing Module (1G06) ARCHITECT c16000 Processing Module (3L77) |
01.10.2021 | 301-228/2021 | LeMaitre Vascular, Inc., ZDA | LifeSpan® ePTFE Vascular Graft |
04.10.2021 | 301-229/2021 | bioMerieux | API® 50 CH Ref. 50300 |
04.10.2021 | 301-230/2021 | bioMérieux SA, FR | VIDAS® HBS AG ULTRA 60 TESTS VIDAS ANTI HBS TOTAL II 60T VIDAS PROGESTERONE 60 TESTS VIDAS HIV DUO QUICK 60 TESTS Obvestilo 1, Priloga 6, Priloga 7, Priloga 9, Priloga 14 |
04.10.2021 | 301-231/2021 | Siemens Healthcare GmbH, DE | Sensis/Sensis Vibe |
04.10.2021 | 301-232/2021 | IMMUNOTECH SAS, FR | Stem-Kit Reagents 50 Tests |
05.10.2021 | 301-62/2021 | Abbott, ZDA | Assurity, Endurity Posodobljeno varnostno obvestilo |
06.10.2021 | 301-297/2019 | Medtronic MiniMed, USA | MiniMed 640G Insulin Pump MiniMed 670G Insulin Pump Posodobljeno varnostno obvestilo 1, Posodobljeno varnostno obvestilo 2 |
07.10.2021 | 301-234/2021 | Hager & Werken GmbH & Co. KG, DE | Fit Kofferdam Klammer |
07.10.2021 | 301-235/2021 | COPAN ITALIA SpA | eSwab Obvestilo 1 |
07.10.2021 | 301-236/2021 | Radiometer Medical ApS, DK | D513 Disposable Waste Container |
08.10.2021 | 301-237/2021 | INTEGRA LifeSciences, ZDA | Accudrain / Hermetic / LimiTorr / MoniTorr |
08.10.2021 | 301-238/2021 | Avanos Medical, Inc., ZDA | CORFLO* Nasointestinal Endoscopically Placed Feeding Tube with ENFit® Connector MIC* Bolus Gastrostomy Feeding Tube with ENFit® Connector CORFLO* Nasointestinal Endoscopically Placed Feeding Tube MIC* Gastrostomy Feeding Tube with ENFit® Connectors MIC* PEG Replacement Feeding Adapter with ENFit® Connectors MIC* Jejunal Feeding Tube with ENFit® Connector MIC* Gastro-Enteric Feeding Tube with ENFit® Connectors MIC* Gastric-Jejunal Feeding Tube Kit with ENFit® Connector ON-Q* Expansion Kits with SOAKER* Catheter ON-Q* Pain Relief System with SOAKER* Catheter ON-Q* Pain Relief System with Dual SILVERSOAKER* Antimicrobial Catheter ON-Q* Pain Relief System with SOAKER* Catheter Obvestilo 1, Obvestilo 2, Obvestilo 3 |
08.10.2021 | 301-239/2021 | Medtronic MiniMed, ZDA | MiniMed™ remote controller (MMT-500, MMT-503) Obvestilo 1, Obvestilo 2 |
12.10.2021 | 301-240/2021 | Philips Medical Systems Nederland BV | Philips Azurion R2.1.x |
13.10.2021 | 301-241/2021 | Medtronic Inc., ZDA | Percept PC BrainSense Obvestilo 1, Priloga |
14.10.2021 | 301-242/2021 | FUJIFILM Irvine Scientific, Inc., ZDA | Vitrification Freeze Kit |
18.10.2021 | 301-116/2021 | Baxter Healthcare SA | Y type Irrigation Set Single Lead Irrigation Set PD 3L Empty Bag System II Posodobljeno varnostno obvestilo, Priloga |
18.10.2021 | 301-208/2021 | Philips Ultrasound, Inc., ZDA | Philips-EPIQ & Affiniti Ultrasound systems Posodobljeno varnostno obvestilo |
19.10.2021 | 301-193/2021 | Smiths Medical ASD, Inc., ZDA | Level 1® Fluid Warmer Level 1® Fluid Warming System Level 1® Normothermic I.V. Fluid Administration Set NORMOFLO® Fluid Warmer NORMOFLO® Irrigation Warming Set |
20.10.2021 | 301-245/2021 | BioFire Diagnostics, LLC, ZDA | BioFire BCID2 Panel |
21.10.2021 | 301-246/2021 | Boston Scientific Corporation, ZDA | Hurricane RX Biliary Balloon Dilatation Catheter |
21.10.2021 | 301-247/2021 | Sente AG, CH | NeoContactAgent |
22.10.2021 | 301-248/2021 | Thoratec Corporation, ZDA | HeartMate Touch |
26.10.2021 | 301-249/2021 | Instrumentation Laboratory Co., ZDA | HemosIL Liquid Anti-Xa |
27.10.2021 | 301-24/2021 | NuVasive, Inc., ZDA | Precice intra-medullary limb lengthening device (IMLL) Posodobljeno varnostno obvestilo, Priloga |
27.10.2021 | 301-251/2021 | Medica S.p.A., IT | A/V SET PROLUNG PLUS 3D |
29.10.2021 | 301-252/2021 | bioMerieux SA, FR | RAPID 20 E™ |