Datum | Številka zadeve | Proizvajalec | Medicinski pripomoček |
---|---|---|---|
02.11.2021 | 301-254/2021 | Zavex Inc., ZDA | FreeGo pump |
04.11.2021 | 301-255/2021 | Siemens Healthcare Diagnostics Inc, ZDA | Dimension Vista Systems |
04.11.2021 | 301-256/2021 | Medline International France SAS | Sterile Surgical Gowns |
05.11.2021 | 301-257/2021 | Medline International France SAS | Surgical Gowns |
08.11.2021 | 301-29/2021 | Gambro Lundia AB, SE | Prismaflex Control Unit Posodobljeno varnostno obvestilo |
08.11.2021 | 301-258/2021 | Life Technologies Corporation, a part of Thermo Fisher Scientific, ZDA | TaqPath™ COVID-19 CE-IVD RT-PCR Kit |
10.11.2021 | 301-259/2021 | Siemens Medical Solutions USA, Inc., ZDA | BIOGRAPH, BIOGRAPH TP, SENSATION 16 AND CARDIAC, BIOGRAPH MCT, BIOGRAPH MCT FLOW, BIOGRAPH HORIZON, BIOGRAPH VISION, BIOGRAPH VISION QUADRA |
12.11.2021 | 301-261/2021 | Sunrise Medical GmbH, DE | Q400F / Q500F |
16.11.2021 | 301-263/2021 | Olympus Medical Systems Corporation, JP | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V |
17.11.2021 | 301-264/2021 | Medtronic Navigation Inc., US | StealthStationTM Cranial and SynergyTM Cranial |
18.11.2021 | 301-265/2021 | Randox Laboratories Ltd, GB | Randox Evidence Investigator |
19.11.2021 | 301-141/2021 | Medtronic Inc, ZDA | Reveal LINQ™ with TruRhythm™ Insertable Cardiac Monitoring Systems Posodobljeno varnostno obvestilo 1, Posodobljeno varnostno obvestilo 2 |
19.11.2021 | 301-230/2021 | bioMérieux SA, FR | VIDAS® LYME IGM 60 TESTS VIDAS® LYME IGG 60 TESTS VIDAS® RUB IGG II 60 TESTS VIDAS® TOXO IGG AVIDITY 30TESTS VIDAS® EBNA IGG 30 TESTS VIDAS® EBV VCA.EA IGG 30 TESTS VIDAS® EBV VCA IGM 30 TESTS VIDAS® HBE.ANTI-HBE 30 TESTS VIDAS® ANTI-HAV TOTAL 30 TESTS VIDAS® T4 60 TESTS VIDAS® IGE 60 TESTS VIDAS® ESTRADIOL II 60 TESTS VIDAS® 25-OH VITAMINE D TOTAL 60T VIDAS® TESTOSTERONE II 30 TESTS VIDAS® SARS-COV-2 IgM (9COM) 60T VIDAS® SARS-COV-2 IgG (9COG) 60T VIDAS® PROTEIN C 30 TESTS Posodobljeno varnostno obvestilo Priloga 1, Priloga 4, Priloga 5, Priloga 7, Priloga 8, Priloga 9, Priloga 10, Priloga 11, Priloga 12, Priloga 13, Priloga 17, Priloga 23, Priloga 29, Priloga 37, Priloga 38, Priloga 46, Priloga 47 |
19.11.2021 | 301-266/2021 | AMO Manufacturing USA, LLC, ZDA | Catalys® and iDesign® |
19.11.2021 | 301-267/2021 | Medtronic Inc., ZDA | Recharger Kit |
19.11.2021 | 301-268/2021 | Datex-Ohmeda, Inc, ZDA | Giraffe Omnibed, Giraffe Omnibed Carestation, Giraffe Incubator, Giraffe Incubator Carestation |
19.11.2021 | 301-269/2021 | GC Tech Europe GmbH, DE | Aadva Twist Drill ( within Aadva Surgical Kit) |
22.11.2021 | 301-270/2021 | Philips Medical Systems Nederland BV, NL | Philips Allura Xper and Azurion systems |
22.11.2021 | 301-271/2021 | BIOTRONIK AG, CH | Passeo-35 Xeo Dynetic-35 |
25.11.2021 | 301-272/2021 | Siemens Healthcare GmbH, DE | Sensis Vibe Hemo & Sensis/ Sensis Vibe Combo |
25.11.2021 | 301-273/2021 | Datascope Corp., ZDA | Cardiosave Intra-Aortic Balloon Pumps |
26.11.2021 | 301-190/2021 | Cordis Corporation, ZDA | SUPER TORQUE® MB Angiographic Catheter Posodobljeno varnostno obvestilo |
30.11.2021 | 301-275/2021 | Hain Life GmbH, DE | GenoType MTBDRplus V. 2.0 / GenoType MTBDRsl V.2. |