April

Datum┼átevilka zadeveProizvajalecMedicinski pripomo─Źek
01.04.2022301-214/2021Abbott Molecular, Inc., ZDAAlinity m SARS-CoV-2 Amplification Reagent Kit Kit (List Numbers 09N78-090 and 09N78-091)
Alinity m Resp-4-Plex Amplification Reagent Kit ( List Number 09N79-090)
Alinity m SARS-CoV-2 Amplification Reagent Kit Emergency Use Authorization (EUA), List Number 09N78-095 (out of EEA only)
Alinity m Resp-4-Plex Amplification Reagent Kit Emergency Use Authorization (EUA), List Number 09N79-096 (out of EEA only)
Posodobljeno varnostno obvestilo
01.04.2022P301-63/2022Richard Wolf GmbH, DECUTTING ELECTRODE BIPO 22FR 12/30┬░ & 24FR 12/30┬░
04.04.2022P301-66/2022Boston Scientific Corporation, ZDA
Promus ELITEÔäó MonorailÔäó Everolimus-Eluting Platinum Chromium
Coronary Stent System – 3.0 x 20mm
04.04.2022P301-67/2022Abbott Molecular, Inc., ZDAAlinity m EBV Amplification Reagent Kit
04.04.2022P301-68/2022Abbott Molecular, Inc., ZDAAlinity m CMV Amplification Reagent kit
06.04.2022P301-69/2022Sirona Dental Systems GmbH, DETeneo
06.04.2022P301-70/2022KARL STORZ SE & Co. KG, DE
Rhino-Laryngo-Fiberscope 3.7 x 34
Rhino-Laryngo-Broncho-Fiberscope
Broncho-Fiberscope 2.8 x 70
Cysto-Urethro-Fiberscope
CMOS Video Cysto-Urethroscope
Ped. Cysto-Urethro-Fiberscope, FLEX-X
Uretero-Reno-Fiberscope FLEX-X2S
Choledocho-Fiberscope, 7.5 Fr.
Choledocho-Fiberscope, 15.5 Fr.
Rhino-Pharyngo-Laryngo-Fiberscope 5.2×23
Cysto-Urethro-Fiberscope, PDD
Uretero-Fiberscope
Uretero-Fiberscope, FLEX-X┬▓
Choledocho-Fiberscope, 11 Fr.

06.04.2022P301-71/2022Phadia AB, SE
Phadia 200, Fluorescent immunoassay analyser IVD, laboratory
07.04.2022301-39/2020Roche Diagnostics GmbH, DEElecsys CA 19-9
Posodobljeno varnostno obvestilo 
07.04.2022P301-72/2022Philips Medical Systems Nederland BV, NLPhilips Azurion R1.x
07.04.2022P301-73/2022SCHILLER AG, CHFRED easyport plus
08.04.2022P301-74/2022Radiometer Medical ApS, DKPICO50 Arterial Blood Sampler
09.04.2022P301-76/2022Abbott Medical, ZDADragonfly Opstar Imaging Catheter
12.04.2022301-277/2020DiaMed GmbH, CHID-DiaCell; ID-Dia Screen; ID-Dia Panel
Posodobljeno varnostno obvestilo 
13.04.2022P301-78/2022WEINMANN Emergency Medical
Technology GmbH, DE
Lithium-Ionen-Akku f├╝r ACCUVAC Pro
14.04.2022P301-49/2022Abbott, ZDAMERLINÔäó & MERLINÔäó 2 PATIENT CARE SYSTEM (PCS)
Posodobljeno varnostno obvestilo 
15.04.2022301-16/2022Arrow International LLC (Subsidiary of
Teleflex Incorporated), ZDA

Arrow: Catheter Introduction Needle, Central Venous Catheter, General
Purpose syringe, Haemostasis valve obturator, Instrument guard, single-use, Vascular
catheter introduction kit, Vascular catheterization support kit
15.04.2022P301-82/2022Siemens Healthcare GmbH, DEAXIOM Sensis XP / Sensis / Sensis Lite
20.04.2022P301-83/2022bioM├ęrieux, Inc., ZDAVITEK┬« 2 System
21.04.2022P301-84/2022BioIntegral Surgical, Inc.
ZDA
BioIntegral Surgical No-React®
21.04.2022P301-85/2022MICROVENTION EUROPE SARL, FRCASPERÔäó Carotid Artery Stent
25.04.2022301-251/2020Siemens Healthcare Diagnostics Inc., ZDAADVIA and Atellica GGT reagent
Posodobljeno varnostno obvestilo 
25.04.2022P301-87/2022CardioTek BV, NLEP-TRACER
25.04.2022P301-88/2022Lohmann & Rauscher GmbH & Co. KG, DEL&R Kitpack (KP), Setpack (SP)
Obvestilo 1, Obvestilo 2, Obvestilo 3
27.04.2022P301-90/2022DiaSys Diagnostic Systems GmbH, DEHDL-c direct FS
28.04.2022P301-91/2022Beckman Coulter InfinityÔäó Ammonia Reagent
29.04.2022P301-92/2022Seegene Inc., KRAllplex SARS-CoV-2 Variants II Assay

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