Datum | Klasifikacijski znak JAZMP | Proizvajalec | Medicinski pripomoček |
---|---|---|---|
01.06.2020 | 301-123/2020 | Dexcom, Inc., ZDA | Dexcom |
03.06.2020 | 301-124/2020 | GE Medical Systems Information Technologies, Inc., ZDA | Patient Data Module |
03.06.2020 | 301-126/2020 | DeVilbiss Healtcare LLC, ZDA | DeVilbis Compact 5 ; Compact 5 / 525KS |
04.06.2020 | 301-125/2020 | Medtronic Inc., ZDA | CareLink SmartSync Base; CareLink SmartSync Patient Connector |
08.06.2020 | 301-128/2020 | Ethicon LLC, ZDA | PERMAHAND™ Silk Suture |
09.06.2020 | 301-306/2019 | ResMed Ltd, AU | Stellar 100/ Stellar 150 Posodobljeno varnostno obvestilo |
09.06.2020 | 301-297/2019 | Medtronic MiniMed, USA | MiniMed 640G Insulin Pump; MiniMed 670G Insulin Pump Posodobljeno varnostno obvestilo 1, Posodobljeno varnostno obvestilo 2 |
09.06.2020 | 301-129/2020 | Life Vascular Devices Biotech, S.L (LVD Biotech), ES | iVascular luminor |
09.06.2020 | 301-130/2020 | Boston Scientific Corporation, ZDA Hemoteq AG, DE | ELUVIA™ Over-The-Wire (OTW) Drug-Eluting Vascular Stent System Ranger™ and Ranger™ SL OTW Paclitaxel-Coated PTA Balloon Catheter |
09.06.2020 | 301-132/2020 | Medtronic, Inc., ZDA | IN.PACT Admiral™ and IN.PACT Pacific™ |
09.06.2020 | 301-133/2020 | Cook Ireland Ltd., IE | Zilver® PTX® Drug-Eluting Peripheral Stent |
09.06.2020 | 301-134/2020 | BIOTRONIK AG, CH | Passeo-18 Lux |
09.06.2020 | 301-135/2020 | Biosensors Europe SA, CH | BioPath 014 & BioPath 035 |
11.06.2020 | 301-136/2020 | Lutonix Inc, ZDA | Lutonix® 014 Drug Coated Balloon PTA Catheter Model: 9005 Lutonix® 035 Drug Coated Balloon Catheter Model: 9004 Lutonix® 014 PTCA Drug Coated Balloon Catheter Model: 9001 |
15.06.2020 | 301-139/2020 | Medtronic Xomed, Inc., ZDA | Console IPC-ENT, Master Console EC300, Powerease IPC, Microdebrider M5 |
16.06.2020 | 301-251/2019 | Medtronic Inc., USA | CareLink™ 2090 Programmers; CareLink Encore™ 29901 Programmers; CareLink SmartSync™ Device Managers; Astra/Azure single- and dual-chamber MR Conditional implantable pacemaker generators; Claria MRI™, Amplia MRI™, Compia MRI™ CRT-D implantable cardioverter defibrillator with cardiac resynchronization therapy and SureScan Technology; Evera™ Implantable Cardioverter-Defibrillator (ICD) Devices; Evera MRI SureScan Implantable Cardioverter Defibrillator; Micra Transcatheter Leadless Pacemaker system; Percepta™, Serena™, Solara™ implantable cardiac pacemakers with cardiac resynchronization therapy (CRT-P) and SureScan Technology; Primo MRI™ and Mirro MRI™ SureScan™ Implantable Cardioverter-Defibrillator (ICD); Visia AF™ and Visia AF MRI™ SureScan™ Single Chamber (VR) Implantable Cardioverter-Defibrillator (ICD); Viva™ and Brava™ Cardiac Resynchronization Therapy-Defibrillation (CRT-D) Devices Posodobljeno varnostno obvestilo |
16.06.2020 | 301-235/2018 | Medtronic Inc., ZDA | CareLink Programmer; CareLink Encore Programmer Posodobljeno varnostno obvestilo |
16.06.2020 | 301-137/2020 | Siemens Healthcare Diagnostics Inc., ZDA | ADVIA Chemistry Calibrator; Atellica Chemistry Calibrator Obvestilo 1, Obvestilo 2 |
16.06.2020 | 301-138/2020 | Terumo BCT Inc., ZDA | Anticoagulant ACD-A solution 750 ml, Anticoagulant ACD-A solution 500 ml & Platelet additive T-PAS+ solution. |
17.06.2020 | 301-140/2020 | Stryker Medical, ZDA | Avtomatski zunanji defibrilator (AED) LIFEPAK® 500 |
18.06.2020 | 301-141/2020 | Willy Rüsch GmbH, DE | Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery |
22.06.2020 | 301-142/2020 | Abbott GmbH, DE | Alinity h‐series (Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module) |
23.06.2020 | 301-143/2020 | Abbott GmbH, DE | Alinity ci-series System Control Module Obvestilo 1, Obvestilo 2, Obvestilo 3 |
23.06.2020 | 301-147/2020 | CIMPAX ApS, DK | CIMPAX Conization Electrode |
24.06.2020 | 301-144/2020 | Siemens Healthcare Diagnostics Products Limited, UK | PRISCA 5 |
25.06.2020 | 301-146/2020 | Bard Access Systems, Inc, ZDA | BARD SafeStep™ Huber Needle Sets |
29.06.2020 | 301-272/2019 | Roche Diagnostics GmbH, DE | Elecsys Troponin T hs. See under “Accessories” Posodobljeno varnostno obvestilo |
29.06.2020 | 301-148/2020 | Drägerwerk AG & Co. KGaA, DE | Only heated Dräger breathing circuits |
30.06.2020 | 301-180/2019 | Roche Diagnostics GmbH, DE | Elecsys Anti-CCP cobas e 411 / 601/ 602/ 801 Modular Analytics E170 Posodobljeno varnostno obvestilo |