Junij

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