Datum | Številka zadeve | Proizvajalec | Medicinski pripomoček |
---|---|---|---|
01.02.2021 | 301-24/2021 | NuVasive, Inc., ZDA | PRECICE System- All iterations- Precice intra-medullary limb lengthening device (IMLL), Precice Short, Precice Unyte, Precice Freedom, Precice Opty-line, Precice Bone Transport, Precice Plate, Precice Stryde Obvestilo 1, Obvestilo 2 |
01.02.2021 | 301-25/2021 | CareDx AB, SE | Olerup QTYPE 11 |
02.02.2021 | 301-108/2020 | Siemens Healthcare Diagnostics Manufacturing Ltd, ZDA | Atellica IM 1300 and IM 1600 Analyzers Posodobljeno varnostno obvestilo |
02.02.2021 | 301-26/2021 | Medtronic Inc., ZDA | Viva™ and Brava™ Cardiac Resynchronization Therapy-Defibrillation (CRT-D) Devices Evera™ Implantable Cardioverter-Defibrillator (ICD) Devices Evera MRI SureScan Implantable Cardioverter Defibrillator (ICD) Devices Visia AF™ and Visia AF MRI™ SureScan™ Single Chamber (VR) Implantable Cardioverter-Defibrillator (ICD) Devices Claria MRI™, Amplia MRI™, Compia MRI™ CRT-D implantable cardioverter defibrillator with cardiac resynchronization therapy and SureScan Technology |
03.02.2021 | 301-27/2021 | Philips Ultrasound Inc., ZDA | Philips-EPIQ Ultrasound system |
03.02.2021 | 301-28/2021 | NIHON KOHDEN Corporation, JP | Multiple Patient Receiver ORG-9200K and ORG-9700K |
04.02.2021 | 301-39/2020 | Roche Diagnostics GmbH, DE | Elecsys CA 19-9 Posodobljeno varnostno obvestilo |
04.02.2021 | 301-168/2019 | Datascope Corp. Getinge, ZDA | Cardiosave, CS100,CS300 Intra-Aortic Balloon Pumps Posodobljeno varnostno obvestilo |
04.02.2021 | 301-29/2021 | Gambro Lundia AB, SE | Prismaflex Control Unit |
08.02.2021 | 301-11/2018 | PACIFIC MEDICO, JP | PMH 7000 Series Posodobljeno varnostno obvestilo |
09.02.2021 | 301-30/2021 | Beaver Visitec International Ltd, GB | BVI CustomEyes Kits and Malosa Kits |
09.02.2021 | 301-31/2021 | Siemens Medical Solutions USA | ACUSON SEQUOIA Diagnostic Ultrasound System |
11.02.2021 | 301-32/2021 | MICROVENTION EUROPE SARL, FR | PHIL – Liquid Embolic |
11.02.2021 | 301-33/2021 | Miltenyi Biotec B.V. & Co. KG, SE | CryoMACS Freezing Bag 750 Obvestilo, Priloga |
11.02.2021 | 301-34/2021 | Olympus Medical Systems Corporation, JP | Olympus TJF-Q170V &TJF-Q190V & TJF-Q290 & MAJ-2315 |
11.02.2021 | 301-35/2021 | Getinge – MAQUET GmbH, DE | MAGNUS Table Column |
15.02.2021 | 301-36/2021 | Drägerwerk AG & Co. KGaA, DE | various: Dräger Neo disposable breathing systems |
15.02.2021 | 301-37/2021 | Medtronic Inc., ZDA | Valiant NavionTM Thoracic Stent Graft System |
18.02.2021 | 301-274/2020 | Getinge Disinfection AB, SE | Getinge CM320-series Posodobljeno varnostno obvestilo |
18.02.2021 | 301-40/2021 | Becton Dickinson Infusion Therapy AB, SE | BD Venflon Pro Safety I.V. Cannula |
22.02.2021 | 301-248/2020 | KARL STORZ SE & Co. KG, DE | HYSTEROMAT E.A.S.I.® SCB Posodobljeno varnostno obvestilo |
22.02.2021 | 301-41/2021 | Philips Goldway (Shenzhen) Industrial Inc., CN | Efficia DFM100 devices |
23.02.2021 | 301-272/2020 | DePuy, IE | Pinnacle Hip System Posodobljeno varnostno obvestilo |
24.02.2021 | 301-42/2021 | Biosense Webster Inc, ZDA | CARTO Vizigo Bi-Directional Guiding Sheath |
24.02.2021 | 301-43/2021 | DiaMed GmbH, CH | DiaClon Anti-M/N DiaClon Anti-N |
24.02.2021 | 301-44/2021 | Riverside Medical Packaging Company Ltd, GB | Aseptic Medical Devices |
25.02.2021 | 301-45/2021 | bioMerieux SA, FR | VIDAS® CMV IgM |
25.02.2021 | 301-46/2021 | RaySearch Laboratories AB (publ), SE | RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, 10A, 10B, including some of the service packs |