18.12.2024 | 301-94/2021 | Roche Diagnostics GmbH, DE | IRON 2 Posodobitev obvestila objavljenega 07.05.2021 |
17.12.2024 | P301-227/2024 | Philips Respironics, Inc., ZDA | Trilogy Evo, Trilogy Evo O2, Trilogy EV300 Posodobitev obvestila objavljenega 17.10.2024 |
06.12.2024 | P301-267/2024 | Philips Healthcare, NL | Philips MR systems dS Breast 7ch 1.5T |
09.12.2024 | P301-268/2024 | EPOCAL, CA | SMN 11413497 |
09.12.2024 | P301-269/2024 | Coloplast 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 |
09.12.2024 | P301-270/2024 | Philips Medical System BV, NL | Allura Xper, Azurion, Integris, MultiDiagnost Eleva |
10.12.2024 | P301-271/2024 | 3M Unitek Corporation, ZDA | 3M™ Transbond™ Self-Etching Primer |
11.12.2024 | P301-272/2024 | Philips Medical System BV, NL | Allura Xper |
11.12.2024 | P301-273/2024 | Max Mobility LLC, ZDA | SpeedControl Dial used with the Smartdrive MX2+ |
11.12.2024 | P301-274/2024 | QuidelOrtho (Ortho Clinical Diagnostics Inc), ZDA | VITROS Chemistry Products DGXN Slides |
12.12.2024 | P301-275/2024 | Cardiac 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) |
12.12.2024 | P301-276/2024 | Maquet Critical Care AB, SE | Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e Priloga 1 Priloga 2 |
13.12.2024 | P301-277/2024 | AMPLITUDE, FR | Acetabular Cup SATURNE II Dual Mobility-HA/Ti coat Cementless-Size 50 |
13.12.2024 | P301-278/2024 | Imaxeon Pty Ltd, AU | Medrad Centargo CT Injection System |
16.12.2024 | P301-279/2024 | Olympus Medical Systems Corporation, JP | Single Use Mechanical Lithotriptor V |
16.12.2024 | P301-280/2024 | BVI Liege/PhysIOL, BE | MICROPURE 123 and ISOPURE 123 |
17.12.2024 | P301-281/2024 | Integra LifeSciences Switzerland SARL, CH | Codman® CERTAS® Plus Programmable Valves |
17.12.2024 | P301-282/2024 | Aesculap AG, DE | HAEMOSTATIC FORCEPS/CLAMPS Priloga 1 Priloga 2 |
17.12.2024 | P301-283/2024 | Olympus Medical Systems Corporation, JP | Thunderbeat Type – S |
18.12.2024 | P301-284/2024 | Olympus Medical Systems Corporation, JP | Forceps/Irrigation Plug (Isolated Type) |
18.12.2024 | P301-285/2024 | GE 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 |
19.12.2024 | P301-287/2024 | Datex-Ohmeda, Inc, ZDA | Tec 6 Plus, Tec 820, Tec 850 |
20.12.2024 | P301-289/2024 | Boston Scientific Corporation, ZDA | AXIOS™ Stent and Electrocautery Enhanced Delivery |
23.12.2024 | P301-290/2024 | QuidelOrtho (Ortho Clinical Diagnostics Inc), ZDA | VITROS Analyser System |