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Datum┼átevilka zadeveProizvajalecMedicinski pripomo─Źek
02.10.2020301-251/2019Medtronic 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
02.10.2020301-214/2020Stryker Neurovascular, ZDATrevo Retriever
02.10.2020301-215/2020Leica Biosystems Newcastle Ltd, UKBOND Enzyme Pretreatment kit
07.10.2020301-217/2020ArjoHuntleigh AB, SEArjo Flat Dynamic Positioning System (DPS)
08.10.2020301-218/2020PAUL HARTMANN AG, DESet za CVK
Set za Bypass
Set TUR
Set RRP
Ginekolo┼íko – vaginalni set
Set varice- laser
15.10.2020301-220/2020Medtronic Inc., ZDAInterStim Percutaneous Extension
16.10.2020301-221/2020Willy R├╝sch GmbH, DELasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery
16.10.2020301-223/2020Draeger Medical Systems, Inc., ZDAInfinity Acute Care System (M540), SW version VG7.1
20.10.2020301-118/2020Smith & Nephew Inc., ZDAR3 Acetabular Shells
Posodobljeno varnostno obvestilo
20.10.2020301-224/2020Siemens Shenzhen Magnetic Resonance Ltd, CNARTIS one
23.10.2020301-225/2020KARL STORZ SE & Co. KG, DEPlastic container for sterilizing
23.10.2020301-226/2020Medtronic CoreValve LLC, ZDAMedtronic CoreValve Evolut R System
Medtronic CoreValve Evolut PRO System
Varnostno obvestilo, Priloga
26.10.2020301-227/2020Laerdal Medical AS, NOLaerdal Compact Suction Unit (LCSU4)
26.10.2020301-228/2020Covidien llc, ZDAPuritan Bennett 980 Ventilator System
27.10.2020301-229/2020TRACOE medical GmbH, DETRACOE twist plus, TRACOE experc Set twist plus
28.10.2020301-223/2019Roche Diagnostics GmbH, DEALB2 (Albumin Gen.2), BILT3 (Bilirubin Total Gen.3)
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29.10.2020301-74/2020Respironics California, LLC, ZDA
(Philips)
V60 ventilators
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30.10.2020301-230/2020AMPLITUDE, FRINITIALE polyethylene cup – Monobloc – cemented
30.10.2020301-231/2020Datex-Ohmeda, Inc., ZDAFLOW SENSOR v medicinskih pripomo─Źkih
Aisys CS2, Avance CS2, Aisys, Avance, Amingo, Aespire View, Aespire 7900, Aespire 7100/100, Aestiva MRI, Aestiva 7900, Aestiva 7100, 9100C NXT
31.10.2020301-39/2020Roche Diagnostics GmbH, DEElecsys CA 19-9
Posodobljeno varnostno obvestilo
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