November

Datum┼átevilka zadeveProizvajalecMedicinski pripomo─Źek
02.11.2021301-254/2021Zavex Inc., ZDAFreeGo pump
04.11.2021301-255/2021Siemens Healthcare Diagnostics Inc, ZDADimension Vista Systems
04.11.2021301-256/2021Medline International France SASSterile Surgical Gowns
05.11.2021301-257/2021Medline International France SASSurgical Gowns
08.11.2021301-29/2021Gambro Lundia AB, SEPrismaflex Control Unit
Posodobljeno varnostno obvestilo
08.11.2021301-258/2021Life Technologies Corporation, a part of Thermo Fisher Scientific, ZDATaqPathÔäó COVID-19 CE-IVD RT-PCR Kit
10.11.2021301-259/2021Siemens Medical Solutions USA, Inc., ZDA
BIOGRAPH, BIOGRAPH TP, SENSATION 16 AND CARDIAC, BIOGRAPH MCT, BIOGRAPH MCT FLOW, BIOGRAPH HORIZON, BIOGRAPH VISION, BIOGRAPH VISION QUADRA
12.11.2021301-261/2021Sunrise Medical GmbH, DEQ400F / Q500F
16.11.2021301-263/2021Olympus Medical Systems Corporation, JPEVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V
17.11.2021301-264/2021Medtronic Navigation Inc., USStealthStationTM Cranial and SynergyTM Cranial
18.11.2021301-265/2021Randox Laboratories Ltd, GBRandox Evidence Investigator
19.11.2021301-141/2021Medtronic Inc, ZDAReveal LINQÔäó with TruRhythmÔäó Insertable Cardiac Monitoring Systems
Posodobljeno varnostno obvestilo 1, Posodobljeno varnostno obvestilo 2
19.11.2021301-230/2021bioM├ęrieux SA, FRVIDAS┬« LYME IGM 60 TESTS
VIDAS® LYME IGG 60 TESTS
VIDAS® RUB IGG II 60 TESTS
VIDAS® TOXO IGG AVIDITY 30TESTS
VIDAS® EBNA IGG 30 TESTS
VIDAS® EBV VCA.EA IGG 30 TESTS
VIDAS® EBV VCA IGM 30 TESTS
VIDAS® HBE.ANTI-HBE 30 TESTS
VIDAS® ANTI-HAV TOTAL 30 TESTS
VIDAS® T4 60 TESTS
VIDAS® IGE 60 TESTS
VIDAS® ESTRADIOL II 60 TESTS
VIDAS® 25-OH VITAMINE D TOTAL 60T
VIDAS® TESTOSTERONE II 30 TESTS
VIDAS® SARS-COV-2 IgM (9COM) 60T
VIDAS® SARS-COV-2 IgG (9COG) 60T
VIDAS® PROTEIN C 30 TESTS
Posodobljeno varnostno obvestilo
Priloga 1, Priloga 4, Priloga 5, Priloga 7, Priloga 8, Priloga 9, Priloga 10, Priloga 11, Priloga 12, Priloga 13, Priloga 17, Priloga 23, Priloga 29, Priloga 37, Priloga 38, Priloga 46, Priloga 47
19.11.2021301-266/2021AMO Manufacturing USA, LLC, ZDACatalys® and iDesign®
19.11.2021301-267/2021Medtronic Inc., ZDARecharger Kit
19.11.2021301-268/2021Datex-Ohmeda, Inc, ZDA
Giraffe Omnibed, Giraffe Omnibed Carestation, Giraffe Incubator, Giraffe Incubator Carestation
19.11.2021301-269/2021GC Tech Europe GmbH, DEAadva Twist Drill ( within Aadva Surgical Kit)
22.11.2021301-270/2021Philips Medical Systems Nederland BV, NLPhilips Allura Xper and Azurion systems
22.11.2021301-271/2021BIOTRONIK AG, CH
Passeo-35 Xeo
Dynetic-35
25.11.2021301-272/2021Siemens Healthcare GmbH, DESensis Vibe Hemo & Sensis/ Sensis Vibe Combo
25.11.2021301-273/2021Datascope Corp., ZDACardiosave Intra-Aortic Balloon Pumps
26.11.2021301-190/2021Cordis Corporation, ZDASUPER TORQUE® MB Angiographic Catheter
Posodobljeno varnostno obvestilo
30.11.2021301-275/2021Hain Life GmbH, DE
GenoType MTBDRplus V. 2.0 / GenoType
MTBDRsl V.2.
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