Junij

DatumKlasifikacijski znak JAZMPProizvajalecMedicinski pripomo─Źek
01.06.2020301-123/2020Dexcom, Inc., ZDADexcom
03.06.2020301-124/2020GE Medical Systems Information Technologies, Inc., ZDAPatient Data Module
03.06.2020301-126/2020DeVilbiss Healtcare LLC, ZDADeVilbis Compact 5 ; Compact 5 / 525KS
04.06.2020301-125/2020Medtronic Inc., ZDACareLink SmartSync Base; CareLink SmartSync Patient Connector
08.06.2020301-128/2020Ethicon LLC, ZDAPERMAHANDÔäó Silk Suture
09.06.2020301-306/2019ResMed Ltd, AUStellar 100/ Stellar 150
Posodobljeno varnostno obvestilo
09.06.2020301-297/2019Medtronic MiniMed, USAMiniMed 640G Insulin Pump; MiniMed 670G Insulin Pump
Posodobljeno varnostno obvestilo 1, Posodobljeno varnostno obvestilo 2
09.06.2020301-129/2020Life Vascular Devices Biotech, S.L  (LVD Biotech), ESiVascular luminor
09.06.2020301-130/2020Boston Scientific Corporation, ZDA

Hemoteq AG, DE
 ELUVIAÔäó Over-The-Wire (OTW) Drug-Eluting Vascular Stent System

RangerÔäó and RangerÔäó SL OTW Paclitaxel-Coated PTA Balloon Catheter
09.06.2020301-132/2020Medtronic, Inc., ZDAIN.PACT AdmiralÔäó and IN.PACT PacificÔäó
09.06.2020301-133/2020Cook Ireland Ltd., IEZilver® PTX® Drug-Eluting Peripheral Stent
09.06.2020301-134/2020BIOTRONIK AG, CHPasseo-18 Lux
09.06.2020301-135/2020Biosensors Europe SA, CHBioPath 014 & BioPath 035
11.06.2020301-136/2020Lutonix Inc, ZDALutonix® 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
15.06.2020301-139/2020Medtronic Xomed, Inc., ZDAConsole IPC-ENT, Master Console EC300, Powerease IPC, Microdebrider M5 
16.06.2020301-251/2019Medtronic Inc., USACareLinkÔäó 2090 Programmers; CareLink EncoreÔäó 29901 Programmers; CareLink SmartSyncÔäó Device Managers;
Astra/Azure single- and dual-chamber MR Conditional implantable pacemaker generators; Claria MRIÔäó, Amplia MRIÔäó, Compia MRIÔäó CRT-D implantable cardioverter defibrillator with cardiac resynchronization therapy and SureScan Technology; EveraÔäó Implantable Cardioverter-Defibrillator (ICD) Devices; Evera MRI SureScan Implantable Cardioverter Defibrillator; Micra Transcatheter Leadless Pacemaker system; PerceptaÔäó, SerenaÔäó, SolaraÔäó implantable cardiac pacemakers with cardiac resynchronization therapy (CRT-P) and SureScan Technology; Primo MRIÔäó and Mirro MRIÔäó SureScanÔäó Implantable Cardioverter-Defibrillator (ICD); Visia AFÔäó and Visia AF MRIÔäó SureScanÔäó Single Chamber (VR) Implantable Cardioverter-Defibrillator (ICD); VivaÔäó and BravaÔäó Cardiac Resynchronization Therapy-Defibrillation (CRT-D) Devices
Posodobljeno varnostno obvestilo
16.06.2020301-235/2018Medtronic Inc., ZDACareLink Programmer; CareLink Encore Programmer
Posodobljeno varnostno obvestilo
16.06.2020301-137/2020Siemens Healthcare Diagnostics Inc., ZDAADVIA Chemistry Calibrator; Atellica Chemistry Calibrator
Obvestilo 1, Obvestilo 2
16.06.2020301-138/2020Terumo BCT Inc., ZDAAnticoagulant ACD-A solution 750 ml, Anticoagulant ACD-A solution 500 ml
&
Platelet additive T-PAS+ solution.
17.06.2020301-140/2020Stryker Medical, ZDAAvtomatski zunanji defibrilator (AED) LIFEPAK® 500
18.06.2020301-141/2020Willy R├╝sch GmbH, DELasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery
22.06.2020301-142/2020Abbott GmbH, DEAlinity hÔÇÉseries (Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module)
23.06.2020301-143/2020Abbott GmbH, DEAlinity ci-series System Control Module
Obvestilo 1, Obvestilo 2, Obvestilo 3
23.06.2020301-147/2020CIMPAX ApS, DKCIMPAX Conization Electrode
24.06.2020301-144/2020Siemens Healthcare Diagnostics Products
Limited, UK
PRISCA 5
25.06.2020301-146/2020Bard Access Systems, Inc, ZDABARD SafeStepÔäó Huber Needle Sets
29.06.2020301-272/2019Roche Diagnostics GmbH, DEElecsys Troponin T hs. See under “Accessories”
Posodobljeno varnostno obvestilo
29.06.2020301-148/2020Dr├Ągerwerk AG & Co. KGaA, DEOnly heated Dr├Ąger breathing circuits
30.06.2020301-180/2019Roche Diagnostics GmbH, DEElecsys Anti-CCP   cobas e 411 / 601/ 602/ 801
Modular Analytics E170
Posodobljeno varnostno obvestilo
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