April

DatumŠtevilka zadeveProizvajalecMedicinski pripomoček
27.02.2026P301-37/2026QIAGEN GmbH, DE670023 ipsogen BCR-ABL1 mbcr Kit CE 97800183
676923 ipsogen WT1 ProfileQuant Kit CE 97800477
97800560
Obvestilo 1
Obvestilo 2
17.03.2026P301-54/2026Cardiac Pacemaker Inc – A wholly owned subsidiary of Guidant Corporation – A wholly owned subsidiary of Boston Scientific Co, ZDAACCOLADE™ 
DR-EL 
CRT-P
Obvestilo 1
Obvestilo 2
Obvestilo 3
Obvestilo 4
26.03.2026P301-60/2026Dexcom, Inc., ZDA
Dexcom G7 iOS CGM App and Dexcom ONE+ iOS CGM App
26.03.2026P301-61/2026Edwards Lifesciences LLC, ZDASwan Ganz Catheters
26.03.2026P301-64/2026Hologic, Inc., ZDA
3Dimensions™ and Selenia® Dimensions® systems
01.04.2026P301-72/2026B·R·A·H·M·S GmbH, part of Thermo Fisher Scientific, DE
B·R·A·H·M·S PlGF Plus KRYPTOR
02.04.2026P301-73/2026Abiomed Inc., ZDA
IMPELLA PURGE CASSETTE
(an accessory to  Impella pump models and to the Automated Impella Controller (AIC))
02.04.2026P301-74/2026Philips Medical Systems Nederland B.V., NLVue PACS v12 ; 1017979
03.04.2026P301-75/2026Philips Respironics, Inc., ZDA 
Trilogy Evo
Trilogy Evo O2
Trilogy EV300 
03.04.2026P301-76/2026DiaMed, CHDiaClon Anti-Cw
08.04.2026P301-77/2026Intuitive Surgical, Inc., ZDAda Vinci X & Xi Surgical System
Obvestilo 1
Obvestilo 2
08.04.2026P301-78/2026Medtronic, Inc., ZDA
SynchroMedTM Clinician Programmer Application
15.04.2026P301-80/2026VitalScientific, FR
GAMMA-GT PLUS SL // GAMMA-GT
16.04.2026P301-81/2026Stryker Neurovascular, ZDA
INZONE DETACHMENT SYSTEM
23.04.2026P301-82/2026D.OR.C. Dutch Ophtalmic Research Center (International) B.V., NLTDC VELOCE™
23.04.2026P301-83/2026Abbott Medical, ZDA
Infinity and Proclaim
Proclaim™ Spinal Cord Stimulation (SCS) Neurostimulation System
Proclaim™ Dorsal Root Ganglion (DRG) Neurostimulation System
Infinity™ Deep Brain Stimulation (DBS) Neurostimulation System
10.04.2026P301-91/2026O&M Halyard, Inc., ZDA
HALYARD* PUREZERO* Ultraviolet* Nitrile Exam Glove
10.04.2026P301-92/2026Arrow International LLC (Subsidiary of Teleflex Incorporated), ZDA
Arrow Haemodialysis Kits and Sets
Izdelek za hemodializno katetrizacijo Arrow Edge®
Antegradni kateter za kronično hemodializo Arrow-Clark™ VectorFlow™
Retrogradni kateter za kronično hemodializo Arrow-Clark™ VectorFlow™
Kateter za kronično hemodializo Cannon® II Plus
Antegradni kateter za kronično hemodializo NextStep®
Retrogradni kateter za kronično hemodializo NextStep®
07.11.2025P301-263/2025Olympus Medical Systems Corporation, JPSINGLE USE LIGATING DEVICE POLYLOOP
Posodobitev obvestila objavljenega novembra 2025
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