Avgust

DatumŠtevilka zadeveProizvajalecMedicinski pripomoček
21.05.2025P301-126/2025Covidien llc. ZDA
Mozarc Medical (Mozarc obvestilo)
Newport HT Ventilator with Accessories, Plus model;
Newport HT70™ Plus Ventilator with oxygen monitoring, SpO2 monitoring, onairway flow sensor;

Newport™ HT70 Plus Ventilator:
HT70PM-WW-NA, HT70PM-SY-EU,
HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-ES-EU,
HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR
HT70PM-SY-AS, DLHT70PM-WW-NA,
HT70PM-WW-EU, HT70PM-WW-UK

Newport™ HT70 Ventilator:
HT70M-JP-NA, HT70M-CN-NA,
HT70M-ES-EU, HT70M-PT-BR,
HT70M-SY-EU, HT70M-WW-EU,
HT70M-WW-NA, HT70-SY-EU
Posodobitev obvestila objavljenega maja 2025, priloga A, priloga B, priloga C, priloga D
25.05.2026P301-99/2026Hamilton Medical AG, CHBreathing circuit set, coaxial for associated ventilators HAMILTON-T1, MR1 and C1
Posodobitev obvestila objavljenega maja 2026
16.07.2026P301-149/2026Remel Europe Ltd, GBNeisseria meningitidis Gp C 2ml/VL
Posodobitev obvestila objavljenega julija 2026
17.07.2026P301-151/2026 BioFire Diagnostics LLC,  ZDA
BIOFIRE FILMARRAY TORCH Base
30.07.2026P301-163/2026Cook Endoscopy/Wilson Cook Medical, Inc., ZDA
Hemospray Endoscopic Hemostat
HEMO-7-EU & HEMO-10-EU
HEMO-7 & HEMO-10
03.08.2026P301-166/2026Fresenius Medical Care AG, DE
Smartbag – Liquid Acid Concentrates
03.08.2026P301-167/2026Andreas Hettich GmbH, DERotofix 32A
05.08.2026P301-168/2026ICU Medical Inc, ZDA
IV Sets or Administration Sets
05.08.2026P301-169/2026Intervascular SAS, FRCARDIOROOT Woven
10.08.2026P301-170/2026Edwards Lifesciences LLC, ZDA
US-MF-000007139
ForeSight Oximeter Cable
HEMFSM10
UDI-DI: 00690103210927
13.08.2026P301-171/2026Philips Medizin Systeme Böblingen GmbH, DE
Patient Information Center iX – 866389, PIC iX Essentials – 867093 
15.05.2026P301-172/2026MicroVention, Inc., ZDA
BOBBY Balloon Guide Catheter
14.08.2026P301-173/2026Gyrus ACMI, Inc. (Olympus Surgical Technologies America)
BiCOAG Hemostasis Probe
CD-B610LA – UDI-DI: 00821925039469
CD-B612LA – UDI-DI: 00821925039476
CD-B620LA – UDI-DI: 00821925039483
CD-B622LA – UDI-DI: 00821925039452
17.08.2026P301-174/2026Balt Extrusion SAS, FR
ANRYV distributed as single unit or part of LEO+, SECLIPSE and Shttps://www.jazmp.si/fileadmin/datoteke/dokumenti/SMP/Varnostna_obvestila/2026/Avgust/P301-177-2026.pdfCOPENIC kits
Accessories/Associated devices: LEO Stent, Copernic anc Eclipse Balloon Catheter.
18.05.2026P301-175/2026Abiomed Inc., ZDA
Automated Impella Controller (AIC)
20.08.2026P301-177/2026Heraeus Medical GmbH, DE
PALACOS® R+G pro, PALACOS® MV+G pro, COPAL® G+C pro
20.08.2026P301-178/2026Boston Scientific Corporation, ZDA
Imager™ II Angiographic Catheter
25.08.2026P301-179/2026Siemens Healthcare Diagnostics Inc., ZDA
Atellica CH Revised C-Reactive Protein (RCRP)
27.08.2026P301-180/2026Philips Medical Systems Nederland B.V., NL
Philips- EPIQ Elite Diagnostic Ultrasound system
27.08.2026P301-181/2026Philips Medical Systems Nederland B.V., NL
Achieva
Ingenia
Intera
Evolution upgrade
MR 5300
MR 7700
SmartPath to dStream
28.08.2026P301-182/2026Philips Medical Systems Nederland BV, NLPhilips Azurion systems
28.08.2026P301-183/2026W. L. Gore & Associates, Inc., NL
GORE® VIABAHN® Endoprosthesis with Heparin/PROPATE
31.08.2026P301-185/2026CX Engineering sp. z o.o., PL
Electric table HE Spectralis BW 110-230V
Priloga

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