September

DatumKlasifikacijski znak JAZMPProizvajalecMedicinski pripomoček
31.08.2019301- 228/2019Cardia International A/S, DKCardiaid, AED Electrodes
02.09.2019301-227/2019Pajunk GmbH Medizintechnologie, DESPROTTE Lumbal
05.09.2019301-184/2018Beckman Coulter, ZDAUniCel DxH 800/600 Cellular Analysis Systems
Posodobljeno varnostno obvestilo
05.09.2019301-229/2019Philips Goldway (Shenzhen) Industrial Inc., PRCEfficiaDFM 100
06.09.2019301-230/2019Mölnlycke Health Care ABBarrier® Sets
09.09.2019301-235/2019Gentherm Medical (Cincinnati Sub-Zero)Model 111Z, Model 111W
10.09.2019301-231/2019Omni-Pac Ekco GmbHMediTainer, MediBowl, MEdiDuo
10.09.2019301-232/2019Datex-Ohmeda, Inc, USAAespire 7100, Aestiva 7900/MRI/7100/100
11.09.2019301-236/2019Mapa GmbH Gummi u.  Plastikwerke, Nemčija21ER  *UMST
AROMA/FEUCHT 24ST *P
AROM/FEUCHT/NOP12
AROMA 6ST
Obvestilo 1Obvestilo 2
12.09.2019301-233/2019Gentherm Medical, LLC (formerly Cincinnati Sub-Zero)Blanketrol III
16.09.2019301-235/2018Medtronic Inc., ZDACareLink Programmer; CareLink Encore Programmer
Posodobljeno varnostno obvestilo
16.09.2019301-181/2018Covidien llc, ZDABIS™ Vista and BIS™ View Monitoring Systems           Posodobljeno varnostno obvestilo
16.09.2019301-237/2019Biocartis NV, BE – BelgiumIdylla™ ctNRAS-BRAF Mutation Test
17.09.2019301-238/2019Siemens Healthcare Diagnostics Inc.Atellica UAS 800 Analyzer
17.09.2019301-240/2019Ortho Clinical Diagnostics Inc. USAVITROS Chemistry Products Cl- & K+ Slides
17.09.2019301-239/2019Johnson & Johnson Vision Care Inc.1-DAY ACUVUE® MOIST®for ASTIGMATISM Contact Lenses
18.09.2019301-234/2019Abbott, DE03R65-01: Alinity i Processing Module

03R67-01: Alinity c Processing Module
20.09.2019301-4/2019Medtronic Inc. ZDAAdapta™, Versa™, Sensia™, Relia™, Attesta™, Sphera™, and Vitatron™ A, E, G, Q series
Posodobljeno varnostno obvestilo 1Posodobljeno varnostno obvestilo 2
20.09.2019301-241/2019EIZO Corporation, JapanRadiForce GX560, RadiForce RX360
20.09.2019301-242/2019Hain Lifescience GmbH, GermanySubstrate Buffer (SUB-D)
24.09.2019301-243/2019Elekta, Inc., USAMOSAIQ®
25.09.2019301-244/2019Biomet Orthopedics, USAVarious Biomet Products
Obvestilo 1Obvestilo 2
26.09.2019301-246/2019Convatec Limited, United KingdomConvex Two-Piece Skin Barriers i.e. Natura /Surfit _ Convex Two-Piece Skin
Barriers i.e. Natura /Surfit
26.09.2019301-247/2019Smith & Nephew Orthopaedics AG, SwitzerlandRT-PLUS MODULAR FEMORAL BLOCK
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