Junij

Datum	Številka zadeve	Proizvajalec	Medicinski pripomoček
02.06.2021	301-140/2021	Medtronic Inc., ZDA	3387S, DBS Lead Kit for Deep Brain Stimulation 3389S, DBS Lead Kit for Deep Brain Stimulation 3391S, DBS Lead Kit 3550S-01, Stimloc Spares Kit 924256, Stimloc Burr Hole Cover DB5000, StimLoc® Support Clips Obvestilo 1, Posodobljeno obvestilo
02.06.2021	301-39/2020	Roche Diagnostics GmbH, DE	Elecsys CA 19-9 Posodobljeno varnostno obvestilo
02.06.2021	301-141/2021	Medtronic Inc, ZDA	Reveal LINQ™ with TruRhythm™ Insertable Cardiac Monitoring Systems
03.06.2021	301-142/2021	Cardiac Pacemaker Inc, ZDA	INGENIO™, VITALIO™ in ADVANTIO™, INLIVEN™, INTUA™ in INVIVE™
03.06.2021	301-209/2018	Cardiac Pacemaker Inc, ZDA	ACCOLADE™, PROPONENT™, ESSENTIO™ , ALTRUA™ 2,  VISIONIST™ in VALITUDE™ Posodobljeno varnostno obvestilo
03.06.2021	301-143/2021	Intersurgical Ltd., VB	INTUBE TRACHEAL TUBE, WIRE REINFORCED CUFFED, 7MM
03.06.2021	301-278/2020	ABBOTT POINT OF CARE, ZDA	i-STAT CG8+ and EG7+ Cartridges Posodobljeno varnostno obvestilo
04.06.2021	301-144/2021	Contura International A/S, DK	Bulkamid Urethral Bulking System
08.06.2021	301-102/2021	Medtronic Inc., ZDA	“DAR™ airway products” Posodobljeno varnostno obvestilo
08.06.2021	301-145/2021	BioFire Diagnostics, LLC, ZDA	PN plus Panel
09.06.2021	301-146/2021	B·R·A·H·M·S GmbH, part of Thermo Fisher Scientific, DE	B·R·A·H·M·S Solution 2 KRYPTOR GOLD Obvestilo 1, Posodobljeno obvestilo
10.06.2021	301-147/2021	Boddingtons, VB	Endocuff Vision
11.06.2021	301-148/2021	Medtronic CoreValve LLC, ZDA	Medtronic CoreValveTM EvolutTM R System, Medtronic CoreValveTM EvolutTM PRO System
11.06.2021	301-149/2021	Fritz Stephan GmbH, DE	EVE IN; EVE TR;  EVE NEO
11.06.2021	301-150/2021	GE Medical Systems Information Technologies, Inc., ZDA	CASE / CardioSoft Cardiac Testing System
14.06.2021	301-151/2021	Abbott GmbH, DE	Activated Alanine Aminotransferase Obvestilo 1, Obvestilo 2
14.06.2021	301-152/2021	Respironics, Inc., (Philips), ZDA	Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30 und BiPAP A30/A40 Series Obvestilo
14.06.2021	301-153/2021	Respironics, Inc., (Philips), ZDA	CPAP and Bi-Level PAP Devices Obvestilo
18.06.2021	301-43/2021	DiaMed GmbH, CH	DiaClon Anti-M/N DiaClon Anti-N Posodobljeno varnostno obvestilo
22.6.2021	301-137/2021	Roche Diagnostics GmbH, DE	cobas 6500 urine analyzer series with software version 2.2.0 – 2.2.9 and 2.3.0 – 2.3.6 cobas u 701 microscopy analyzer standalone with software version 2.2.0 – 2.2.9 and 2.3.0 – 2.3.6 Posodobljeno varnostno obvestilo
22.6.2021	301-156/2021	Sony Corporation, JP	LCD Monitor LMD-X270x
24.06.2021	301-157/2021	Roche Diagnostics GmbH, DE	cobas u pack
24.06.2021	301-158/2021	Philips Goldway (Shenzhen) Industrial Inc., CN	Philips HeartStart Intrepid Monitor/Defibrillator
24.06.2021	301-269/2020	Ortho Clinical Diagnostics Inc, ZDA	VITROS Chemistry Products CKMB Slides Posodobljeno varnostno obvestilo
25.06.2021	301-159/2021	ETHICON Sarl, CH	INTERCEED Absorbable Adhesion Barrier