Junij

DatumŠtevilka zadeveProizvajalecMedicinski pripomoček
24.06.2026P301-16/2026Datascope Corp., ZDACS100 and CS300 Intra-Aortic Balloon Pumps
Posodobitev obvestila objavljenega januarja 2026
30.06.2026P301-55/2026Medtronic, Inc.ZDASphere-9™ Catheter
Basic UDI-DI: 0763000B000262284
Posodobitev obvestila objavljenega marca 2026
Priloga
04.06.2026P301-72/2026B·R·A·H·M·S GmbH, part of Thermo Fisher Scientific, DEB·R·A·H·M·S PlGF Plus KRYPTOR
Posodobitev obvestila objavljenega aprila 2026
25.06.2026P301-77/2025MAQUET Cardiovascular, LLC, ZDACARDIOSAVE Hybrid – Ultrasonic Doppler
Posodobitev obvestila objavljenega aprila 2025
22.06.2026P301-101/2025Datascope Corp., ZDACardiosave
Hybrid Intra-Aortic Balloon Pump (IABP) devices
CARDIOSAVE RESCUE, 3.1 EDITION
CARDIOSAVE HYBRID, 3.1 EDITION
CARDIOSAVE HYBRID – TYPE “N” PLUG
CARDIOSAVE HYBRID, TYPE B PLUG
CARDIOSAVE RESCUE
CARDIOSAVE RESCUE, CHINESE
CARDIOSAVE HYBRID W/ E/F PLUG
CARDIOSAVE HYBRID, TYPE G PLUG
CARDIOSAVE HYBRID, TYPE I PLUG
CARDIOSAVE HYBRID TYPE K PLUG
CARDIOSAVE HYBRID TYPE J PLUG
Posodobitev obvestila objavljenega aprila 2025
03.06.2026P301-111/2026Philips Medizin Systeme Böblingen, DECardiotocograph
03.06.2026P301-112/2026Medical (Physio-Control Inc.), Masimo Corporation, ZDA
Masimo SPCO/SpMet Sensors
03.06.2026P301-113/2026Siemens Healthcare Diagnostics Inc., ZDARAPIDLab 348Ex System
05.06.2026P301-114/2026IntersurgicaL Ltd., VBOne-piece Guedel airway
05.06.2026P301-115/2026Hamilton Medical AG, CHIntelliCuff
08.06.2026P301-116/2026WEINMANN Emergency Medical Technology GmbH, DE
MEDUMAT Standard², mit und ohne CO2
WM 28710-01
MEDUMAT Standard², ventilator, osnovna naprava brez merjenja CO2
WM 28710-02
MEDUMAT Standard², ventilator, osnovna naprava z merjenjem CO2
WM 28710-03
MEDUMAT Standard², ventilator, osnovna naprava brez merjenja CO2 in s priključkom za plin pod tlakom na zadnji strani
WM 28710-04
MEDUMAT Standard², ventilator, osnovna naprava z merjenjem CO2 in priključkom za plin pod tlakom na zadnji strani
WM 29300
MEDUMAT Standard², ventilator, brez merjenja CO2
WM 29500
MEDUMAT Standard², ventilator z merjenjem CO2
WM 29350
MEDUMAT Standard², ventilator brez merjenja CO2 in s priključkom za plin pod tlakom na zadnji strani
WM 29550
MEDUMAT Standard², ventilator z merjenjem CO2 in priključkom za plin pod tlakom na zadnji strani
10.06.2026P301-117/2026Boston Scientific Corporation, ZDA
FARADRIVE Steerable Sheath
12.06.2026P301-118/2026Olympus Medical Systems Corporation, JP
High Flow Insufflation Unit
UHI-4
12.06.2026P301-119/2026Abiomed Inc., DE
Automated Impella Controller (AIC)
15.06.2026P301-120/2026Waismed ltd, Izrael (IL)NIO Pediatric
15.06.2026P301-121/2026Philips Medical Systems Nederland BV, NL
Philips Allura and Azurion systems
15.06.2026P301-122/2026CAIR LGL, FR
Prolongateur moyenne pression diam.1,5mm
15.06.2026P301-123/2026Intergra Lifesciences Corporation, ZDAIntegra Omni-Tract Table Mounted Retractor Syst
Priloga 1
Priloga 2
17.06.2026P301-124/2026STAAR Surgical AG, CH
ICL/TICL Calculator/IOD Software
19.06.2026P301-125/2026Immucor GTI Diagnostics, Inc., ZDALIFECODES LSA Class II Kit
Priloga 1
Priloga 2
18.06.2026P301-126/2026Siemens Healthcare Diagnostics Inc., ZDA
Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
23.06.2026P301-128/2026Jafron Biomedical Co., Ltd., CN
Disposable Hemoperfusion Cartridge
24.06.2026P301-129/2026Medtronic Inc., ZDA
78222, 78322: EOPA 3D® Arterial Cannula 22 Fr
77622, 77722, 77422, 77522: EOPA™ – Elongated One Piece Arterial Cannula 22 Fr.
24.06.2026P301-130/2026Philips Medical Systems Nederland BV, NLPhilips Allura and Azurion
25.06.2026P301-133/2026Löwenstein Medical SE & Co. KG, DELeoni Plus
25.06.2026P301-134/2026Olympus Medical Systems Corporation, JP Single Use Distal Cover
25.06.2026P301-135/2026Therakos Development Limited, IE
THERAKOS CELLEX Photopheresis Procedural Kit
23.06.2026P301-136/2026Resmed Pty Ltd, AUS
AU-MF-000011753		Astral 100, Astral 150
Priloga 1
Priloga 2
Priloga 3
30.06.2026P301-137/2026MEDIMA Sp. z o.o., PL
Volumetric infusion pump administration sets

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