Datum | Številka zadeve | Proizvajalec | Medicinski pripomoček |
---|---|---|---|
07.03.2025 | P301-238/2024 | Bard Access Systems, Inc, ZDA | 4Fr Single-Lumen PowerPICC SOLO 4Fr Single-Lumen PowerPICC Posodobitev obvestila objavljenega oktobra 2024 |
26.03.2025 | P301-161/2024 | Zevex Inc. (Moog Medical Devices), ZDA | FreeGo Pump Posodobitev obvestila objavljenega julija 2024 |
25.02.2025 | P301-50/2025 | ZOLL Medical Corporation, ZDA | Powerheart® G5 AED, Semi-Automatic/ Automatic, G5X |
19.03.2025 | P301-222/2024 | Datex-Ohmeda, Inc, ZDA | Giraffe Omnibed Carestation CS1; Giraffe Omnibed Posodobitev obvestila objavljenega oktobra 2024 |
09.10.2024 | P301-220/2024 | Miele & Cie. KG, DE | Olympus ETD PAA Premium |
26.03.2025 | P301-104/2024 | Medtronic Inc., ZDA | 8780 / 8781: Ascenda Intrathecal Catheter 8784: Ascenda Intrathecal Catheter Pump Segment Revision Kit Posodobitev obvestila objavljenega maja 2024 |
11.03.2025 | P301-174/2024 | Datex-Ohmeda, Inc., ZDA | Aespire 7100, Aespire 100, S/5 Aespire 7900 (GTIN-00840682102261) Aespire View (GTIN-00840682102285) Avance, Amingo, Avance CS2 and Avance CS2 Pro (GTIN-00840682102322) Aisys, Aisys CS2 (GTIN-00840682102292) Aisys CS2 with Et Control (GTIN-00195278588128) machines configured with ACGO option. Posodobitev obvestila objavljenega avgusta 2024 |
04.03.2025 | P301-53/2025 | Immunotech s.r.o., CZ | Inhibin B Gen II ELISA |
05.03.2025 | P301-54/2025 | Medistim ASA, NO | L15 Ultrasound Imaging Probe model: EL100015 |
05.03.2025 | P301-55/2025 | Immucor GTI Diagnostics (A Werfen Company), ZDA | LIFECODES PakPlus Varnostno obvestilo 1 Varnostno obvestilo 2 |
05.03.2025 | P301-56/2025 | Medtronic, Inc., ZDA | Stimulation RC Clinician Programmer Application |
06.03.2025 | P301-57/2025 | Radiometer Medical ApS, DK | ABL90 FLEX and ABL90 FLEX PLUS Analyzer |
10.03.2025 | P301-58/2025 | Cantel Medical, IT | MEDISA Automated Endoscope Reprocessor (AER) |
07.03.2025 | P301-59/2025 | Datex-Ohmeda, Inc., ZDA | EVair medical air compressor, Evair 03 Varnostno obvestilo 1 Varnostno obvestilo 2 |
12.03.2025 | P301-60/2025 | Baxter Medical Systems GmbH + Co. KG, DE | TruSystem 7500 |
13.03.2025 | P301-61/2025 | MAQUET Cardiovascular, LLC, ZDA | Vasoview Hemopro 2 Endoscopic Vessel Harvesting System VH-4000 and VH-4001 |
13.03.2025 | P301-62/2025 | B. Braun Avitum AG, DE | Single Needle Cross OverSingle-Needle Cross-Over and Single-Needle AV line |
14.03.2025 | P301-63/2025 | Abbott Diagnostics Scarborough, Inc., ZDA | ID NOW COVID-19 2.0 24T OUS Varnostno obvestilo 1 Varnostno obvestilo 2 |
14.03.2025 | P301-64/2025 | Philiips Healthcare (Suzhou) Co., Ltd, CN | DuraDiagnost , DuraDiagnost Compact Model: 712203 |
17.03.2025 | P301-65/2025 | Abbott Medical, ZDA | Amplatzer TorqVue LP Delivery System / Catheter |
18.03.2025 | P301-66/2025 | AMPLITUDE, FR | EVOK® Femoral Stem – Standard Offset – Collarless |
19.03.2025 | P301-67/2025 | Carnamedica Sp. z o.o., PL | PlegiStore®, LungProtect®, CelProtect®, StoreProtect Plus®, StoreProtect®/ Belzer UW® Cold Storage Solution (University of Wisconsin Solution), PumpProtect®/ Belzer MPS® (UW Machine Perfusion Solution). |
19.03.2025 | P301-68/2025 | Medtronic CoreValve LLC, ZDA | Evolut PRO+ Transcatheter Aortic Valve (23/26/29/34 mm) Medtronic Evolut FX Transcatheter Aortic Valve (23/26/29/34 mm) Medtronic Evolut FX+ Transcatheter Aortic Valve (23/26/29/34 mm) |
21.03.2025 | P301-69/2025 | Abbott Laboratories, ZDA | CELL-DYN Ruby catalogue number: 08H67-01, 08H67-03 |
21.03.2025 | P301-70/2025 | ROCAMED, FR | Endoflow II Irrigation and Warming System and associated irrigation/suction tubings |
24.03.2025 | P301-71/2025 | Avanos Medical Inc., ZDA | Ballard Closed Suction System |
25.03.2025 | P301-72/2025 | Hill-Rom, Inc., ZDA | Progressa |
25.03.2025 | P301-73/2025 | Abbott Molecular, Inc., ZDA | Alinity m System 08N53-01 Alinity m System 08N53-02 Alinity m System Refurbished 08N53-32 |
25.03.2025 | P301-74/2025 | LeMaitre Vascular, Inc., ZDA | Flexcel™ Carotid Shunt Model: 2020-25M / 2020-21M, 2020-35M / 2020-31M |
26.03.2025 | P301-75/2025 | Philips Medical Systems Nederland B.V., NL | Vue PACS (Diagnostic) |
26.03.2025 | P301-76/2025 | EPOCAL Inc., CA | Epoc BGEM Test Card |
26.03.2025 | P301-77/2025 | MAQUET Cardiovascular, LLC, ZDA | CARDIOSAVE Hybrid – Ultrasonic Doppler |
27.03.2025 | P301-78/2025 | SCHILLER AG, CH | FRED easyport |
27.03.2025 | P301-79/2025 | Siemens Healthcare Diagnostics Inc, ZDA | Atellica CH Revised C-Reactive Protein (RCRP) |
27.03.2025 | P301-80/2025 | Datex-Ohmeda, Inc, ZDA | Carestation 600 and 750 Series |