Oktober

Datum	Številka zadeve	Proizvajalec	Medicinski pripomoček
02.10.2020	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
02.10.2020	301-214/2020	Stryker Neurovascular, ZDA	Trevo Retriever
02.10.2020	301-215/2020	Leica Biosystems Newcastle Ltd, UK	BOND Enzyme Pretreatment kit
07.10.2020	301-217/2020	ArjoHuntleigh AB, SE	Arjo Flat Dynamic Positioning System (DPS)
08.10.2020	301-218/2020	PAUL HARTMANN AG, DE	Set za CVK Set za Bypass Set TUR Set RRP Ginekološko – vaginalni set Set varice- laser
15.10.2020	301-220/2020	Medtronic Inc., ZDA	InterStim Percutaneous Extension
16.10.2020	301-221/2020	Willy Rüsch GmbH, DE	Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery
16.10.2020	301-223/2020	Draeger Medical Systems, Inc., ZDA	Infinity Acute Care System (M540), SW version VG7.1
20.10.2020	301-118/2020	Smith & Nephew Inc., ZDA	R3 Acetabular Shells Posodobljeno varnostno obvestilo
20.10.2020	301-224/2020	Siemens Shenzhen Magnetic Resonance Ltd, CN	ARTIS one
23.10.2020	301-225/2020	KARL STORZ SE & Co. KG, DE	Plastic container for sterilizing
23.10.2020	301-226/2020	Medtronic CoreValve LLC, ZDA	Medtronic CoreValve Evolut R System Medtronic CoreValve Evolut PRO System Varnostno obvestilo, Priloga
26.10.2020	301-227/2020	Laerdal Medical AS, NO	Laerdal Compact Suction Unit (LCSU4)
26.10.2020	301-228/2020	Covidien llc, ZDA	Puritan Bennett 980 Ventilator System
27.10.2020	301-229/2020	TRACOE medical GmbH, DE	TRACOE twist plus, TRACOE experc Set twist plus
28.10.2020	301-223/2019	Roche Diagnostics GmbH, DE	ALB2 (Albumin Gen.2), BILT3 (Bilirubin Total Gen.3) Posodobljeno varnostno obvestilo
29.10.2020	301-74/2020	Respironics California, LLC, ZDA (Philips)	V60 ventilators Posodobljeno varnostno obvestilo
30.10.2020	301-230/2020	AMPLITUDE, FR	INITIALE polyethylene cup – Monobloc – cemented
30.10.2020	301-231/2020	Datex-Ohmeda, Inc., ZDA	FLOW SENSOR v medicinskih pripomočkih Aisys CS2, Avance CS2, Aisys, Avance, Amingo, Aespire View, Aespire 7900, Aespire 7100/100, Aestiva MRI, Aestiva 7900, Aestiva 7100, 9100C NXT
31.10.2020	301-39/2020	Roche Diagnostics GmbH, DE	Elecsys CA 19-9 Posodobljeno varnostno obvestilo