Julij

DatumŠtevilka zadeveProizvajalecMedicinski pripomoček
24.07.2025P301-247/2022Datascope Corp. Getinge, USACardiosave Intra-Aortic Balloon Pumps
Posodobitev obvestila objavljenega decembra 2022
29.07.2025P301-248/2023BioFire Diagnosticss, LLC, ZDABIOFIRE FILMARRAY TORCH
Posodobitev obvestila objavljenega novembra 2023
23.07.2025P301-258/2024Immunotech S.A.S., FRAccess hsTnI Reagent Kit
Posodobitev obvestila objavljenega novembra 2024
21.07.2025P301-61/2025MAQUET Cardiovascular, LLC, ZDAVasoview Hemopro 2 Endoscopic Vessel Harvesting System
VH-4000 and VH-4001
Posodobitev obvestila objavljenega marca 2025
08.07.2025P301-63/2025Abbott Diagnostics Scarborough, Inc., ZDAID NOW COVID-19 2.0 24T OUS
Posodobitev obvestila objavljenega marca 2025
10.07.2025P301-163/2023Datascope Corp., ZDADatascope Cardiosave Hybrid in Rescue intraaortna balonska črpalka (IABP)
Posodobitev obvestila objavljenega avgusta 2023
11.07.2025P301-74/2024Masimo Corporation, ZDARad-G Pulse Oximeter
Posodobitev obvestila objavljenega marca 2024
21.07.2025P301-264/2024Maquet Cardiovascular, LLC, ZDA /Getinge VASOVIEW HEMOPRO, VASOVIEW HEMOPRO 2
Posodobitev obvestila objavljenega novembra 2024
12.06.2025P301-122/2025Dexcom, Inc.,ZDA
Dexcom One, Dexcom G7, and Dexcom One+ Receivers
00386270002129 (STK-GT-109) 
17.07.2025P301-22/2025Philips Medical Systems Nederland BV, NLPhillips Allura in Azurion
Posodobitev obvestila objavljenega januarja 2025
12.06.2025P301-142/2025Philips (Volcano Corporation), ZDA
Visions PV .014P RX and .018 Digital IVUS Catheter
13.06.2025P301-145/2025Philips Medical Systems (Cleveland), Inc., ZDA
Pinnacle Radiation Therapy Planning System
20.06.2025P301-151/2025Abiomed Inc., ZDA
Automated Impella Controller (AIC)
26.06.2025P301-156/2025QuidelOrtho (Ortho Clinical Diagnostics Inc), ZDA
VITROS Chemistry Products Performance Verifier I et II
30.06.2025P301-159/2025Ambu A/S, DKAmbu® SPUR® II
01.07.2025P301-160/2025Waldemar Link GmbH & Co.KG, DE
LINK Prosthesis Head B  Ø 28 mm and Trial Head
04.07.2025P301-161/2025bioMérieux, Inc., ZDAVITEK 2AST test Kit
07.07.2025P301-162/2025Beckman Coulter, ZDA973100 – UniCel DxI 800 Access Immunoassay Analyzer
A71457 – DxI 800 Access Immunoassay Analyzer W/Dual Gantry
A71456 – DxI 800 Access Immunoassay Analyzer W/Spot B
A30260 – UniCel DxI 600 Access Immunoassay Analyzer
A71461 – DxI 600 Access Immunoassay Analyzer W/Dual Gantry
A71460 – DxI 600 Access Immunoassay Analyzer W/Spot B
Obvestilo
Priloga
07.07.2025P301-163/2025Becton, Dickinson and Company, ZDA
BD Vacutainer® Pronto™ Quick Release Needle Holder
07.07.2025P301-164/2025Boston Scientific Corporation, ZDA
Carotid WALLSTENT™ Monorail Endoprosthesis
04.07.2025P301-165/2025SOLUSCOPE SAS, FR
SOLUSCOPE SERIE 1 SL-V1-AL-PA
SOLUSCOPE SERIE 4
04.07.2025P301-166/2025Siemens Healthcare Diagnostics Inc., ZDA
Atellica CH Diazo Total Bilirubin (D_TBil)
14.07.2025P301-168/2025EPOCAL, CAEpoc BGEM Test Cards
14.07.2025P301-169/2025Dexcom, Inc., ZDA
Dexcom G7 CGM App and Dexcom ONE+ CGM App
15.07.2025P301-170/2025QuidelOrtho (Ortho Clinical Diagnostics Inc), ZDA
VITROS Chemistry Products Calcium Slides
16.07.2025P301-171/2025Philips Medical Systems Nederland B.V., NL
Achieva 3.0T – 781177, 781277,  781278,  781344,  781345,
Achieva XR – 781153, 781253
Evolution upgrade 1.5T – 782116, 782148
Evolution upgrade 3.0T – 782117, 782143
Ingenia 1.5T – 781315,  781341,  781396,  782101,  782115,  782140
Ingenia 1.5T S – 781347
Ingenia 3.0T – 781342,  781377,  782103
Ingenia 3.0T CX – 781271,  782105
Ingenia Ambition S – 781359,  782108,  782133,  782139
Ingenia Ambition X – 781356,  782109,  782138
Ingenia Elition S – 781357,  782106,  782137,  782150
Ingenia Elition X – 781358,  782107,  782119,  782136,  782151
Intera 3.0T Quasar Dual – 781150
MR 5300 – 782110,  782135,  782152
MR 7700 – 782120, 782153
SmartPath to dStream for 3.0T – 782145,
SmartPath to dStream for XR and 3.0T – 781270, 782113, 782129
SmartPath to Ingenia Elition X – 782118, 782144
Upgrade to MR 7700 – 782130
17.07.2025P301-172/2025Fresenius Kabi AG, DEAgilia Connect VP
22.07.2025P301-173/2025Olympus Winter & Ibe GmbH, DEElectrosurgical Generator – ESG-410
Obvestilo 1
Obvestilo 2
24.07.2025P301-174/2025Cardiac Pacemaker Inc – A wholly owned subsidiary of Guidant Corporation – A wholly owned subsidiary of Boston Scientific CorporationENDOTAK RELIANCE
28.07.2025P301-175/2025Nipro Corporation, JPHAEMODIALYSIS EQUIPMENT
Obvestilo 1
Obvestilo 2
25.07.2025P301-176/2025Siemens Healthcare Diagnostics Products
GmbH, DE		INNOVANCE VWF Ac
18.07.2025P301-177/2025Boston Scientific Corporation, ZDA
Acurate neo2 and Prime Aortic Valve System
29.07.2025P301-179/2025Boston Scientific Corporation, ZDA
WATCHMAN TruSeal™ Access System
WATCHMAN FXD Curve™ Access System
30.07.2025P301-181/2025Contract Medical International GmbH, DE
Fortress Introducer Sheath System, 6F Straight 45c
31.07.2025P301-182/2025GS Elektromedizinische Geräte G. Stemple GmbH, DEcorpuls3, corpuls3 Touch

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