December

DatumŠtevilka zadeveProizvajalecMedicinski pripomoček
18.12.2024301-94/2021Roche Diagnostics GmbH, DEIRON 2
Posodobitev obvestila objavljenega 07.05.2021
17.12.2024P301-227/2024Philips Respironics, Inc., ZDATrilogy Evo, Trilogy Evo O2, Trilogy EV300
Posodobitev obvestila objavljenega 17.10.2024
06.12.2024P301-267/2024Philips Healthcare, NL
Philips MR systems
dS Breast 7ch 1.5T
09.12.2024P301-268/2024EPOCAL, CASMN 11413497 
09.12.2024P301-269/2024Coloplast A/S, DK
Foley catheters (class IIb devices)
– Prostatic catheters (class IIa devices)
– Urinary diversion devices (class IIa devices)
– Neoplex® urethral catheters without balloon (class Is devices)
– Urethral bougies (class Is devices)
– Urodynamic catheters (class IIa devices)
– Percutaneous nephrostomy catheters (class IIb devices)
– Supra-pubic drainage set (class IIb devices)
– Surgical drainage devices (class IIa devices)

Priloga 1
09.12.2024P301-270/2024Philips Medical System BV, NL
Allura Xper, Azurion, Integris, MultiDiagnost Eleva
10.12.2024P301-271/20243M Unitek Corporation, ZDA
3M™ Transbond™ Self-Etching Primer
11.12.2024P301-272/2024Philips Medical System BV, NLAllura Xper
11.12.2024P301-273/2024Max Mobility LLC, ZDA
SpeedControl Dial used with the Smartdrive MX2+
11.12.2024P301-274/2024QuidelOrtho (Ortho Clinical Diagnostics Inc), ZDA
VITROS Chemistry Products DGXN Slides
12.12.2024P301-275/2024Cardiac Pacemaker Inc, ZDA
ACCOLADE™ family:ACCOLADE, PROPONENT™, ESSENTIO™, and ALTRUA™ 2 Standard Life (SL) and Extended Life (EL) pacemakers; and the VISIONIST™
• VALITUDE™ cardiac resynchronization therapy pacemakers (CRT-P)
12.12.2024P301-276/2024Maquet Critical Care AB, SEFlow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
Priloga 1
Priloga 2
13.12.2024P301-277/2024AMPLITUDE, FR
Acetabular Cup SATURNE II Dual Mobility-HA/Ti coat
Cementless-Size 50
13.12.2024P301-278/2024Imaxeon Pty Ltd, AU
Medrad Centargo CT Injection System
16.12.2024P301-279/2024Olympus Medical Systems Corporation, JP
Single Use Mechanical Lithotriptor V
16.12.2024P301-280/2024BVI Liege/PhysIOL, BE
MICROPURE 123 and ISOPURE 123
17.12.2024P301-281/2024Integra LifeSciences Switzerland SARL, CH
Codman® CERTAS® Plus Programmable Valves
17.12.2024P301-282/2024Aesculap AG, DEHAEMOSTATIC FORCEPS/CLAMPS
Priloga 1
Priloga 2
17.12.2024P301-283/2024Olympus Medical Systems Corporation, JPThunderbeat Type – S
18.12.2024P301-284/2024Olympus Medical Systems Corporation, JP
Forceps/Irrigation Plug (Isolated Type)
18.12.2024P301-285/2024GE Hualun Medical Systems Co. Ltd, CN
GE Medical Systems Israel, Functional Imaging, IL

Infinia
§ Infinia Hawkeye
§ Infinia II
§ Infinia II Hawkeye 4
Varicam
§ Millennium VG
§ Millennium VG Hawkeye
§ Discovery VH
Brivo NM 615
Discovery NM 630
Discovery NM/CT 670
Discovery NM/CT 670 ES
Discovery NM/CT 670 DR
Discovery NM/CT 670 PRO
Discovery NM/CT 670 CZT
Optima NM/CT 640
19.12.2024P301-287/2024Datex-Ohmeda, Inc, ZDA
Tec 6 Plus, Tec 820, Tec 850
20.12.2024P301-289/2024Boston Scientific Corporation, ZDA
AXIOS™ Stent and Electrocautery Enhanced Delivery
23.12.2024P301-290/2024QuidelOrtho (Ortho Clinical Diagnostics Inc), ZDAVITROS Analyser System

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