SEPTEMBER

Datum Klasifikacijski znak JAZMP Proizvajalec Medicinski pripomoček
31.08.2019 301- 228/2019 Cardia International A/S, DK Initiates file downloadCardiaid, AED Electrodes
02.09.2019 301-227/2019 Pajunk GmbH Medizintechnologie, DE Initiates file downloadSPROTTE Lumbal
05.09.2019 301-184/2018 Beckman Coulter, ZDA Initiates file downloadUniCel DxH 800/600 Cellular Analysis Systems
Posodobljeno varnostno obvestilo
05.09.2019 301-229/2019 Philips Goldway (Shenzhen) Industrial Inc., PRC Initiates file downloadEfficiaDFM 100
06.09.2019 301-230/2019 Mölnlycke Health Care AB Initiates file downloadBarrier® Sets
09.09.2019 301-235/2019 Gentherm Medical (Cincinnati Sub-Zero) Initiates file downloadModel 111Z, Model 111W
10.09.2019 301-231/2019 Omni-Pac Ekco GmbH Initiates file downloadMediTainer, MediBowl, MEdiDuo
10.09.2019 301-232/2019 Datex-Ohmeda, Inc, USA Initiates file downloadAespire 7100, Aestiva 7900/MRI/7100/100
11.09.2019 301-236/2019 Mapa GmbH Gummi u.  Plastikwerke, Nemčija 21ER  *UMST
AROMA/FEUCHT 24ST *P
AROM/FEUCHT/NOP12
AROMA 6ST
Obvestilo 1, Initiates file downloadObvestilo 2
12.09.2019 301-233/2019 Gentherm Medical, LLC (formerly Cincinnati Sub-Zero) Initiates file downloadBlanketrol III
16.09.2019 301-235/2018 Medtronic Inc., ZDA CareLink Programmer; CareLink Encore Programmer
Initiates file downloadPosodobljeno varnostno obvestilo
16.09.2019 301-181/2018 Covidien llc, ZDA BIS™ Vista and BIS™ View Monitoring Systems           Initiates file downloadPosodobljeno varnostno obvestilo
16.09.2019 301-237/2019 Biocartis NV, BE - Belgium Initiates file downloadIdylla™ ctNRAS-BRAF Mutation Test
17.09.2019 301-238/2019 Siemens Healthcare Diagnostics Inc. Initiates file downloadAtellica UAS 800 Analyzer
17.09.2019 301-240/2019 Ortho Clinical Diagnostics Inc. USA Initiates file downloadVITROS Chemistry Products Cl- & K+ Slides
17.09.2019 301-239/2019 Johnson & Johnson Vision Care Inc. Initiates file download1-DAY ACUVUE® MOIST®for ASTIGMATISM Contact Lenses
18.09.2019 301-234/2019 Abbott, DE Initiates file download03R65-01: Alinity i Processing Module

03R67-01: Alinity c Processing Module
20.09.2019 301-4/2019 Medtronic Inc. ZDA Adapta™, Versa™, Sensia™, Relia™, Attesta™, Sphera™, and Vitatron™ A, E, G, Q series
Posodobljeno varnostno obvestilo 1, Posodobljeno varnostno obvestilo 2
20.09.2019 301-241/2019 EIZO Corporation, Japan Initiates file downloadRadiForce GX560, RadiForce RX360
20.09.2019 301-242/2019 Hain Lifescience GmbH, Germany Initiates file downloadSubstrate Buffer (SUB-D)
24.09.2019 301-243/2019 Elekta, Inc., USA Initiates file downloadMOSAIQ®
25.09.2019 301-244/2019 Biomet Orthopedics, USA Various Biomet Products
Obvestilo 1, Initiates file downloadObvestilo 2
26.09.2019 301-246/2019 Convatec Limited, United Kingdom Initiates file downloadConvex Two-Piece Skin Barriers i.e. Natura /Surfit _ Convex Two-Piece Skin
Barriers i.e. Natura /Surfit
26.09.2019 301-247/2019 Smith & Nephew Orthopaedics AG, Switzerland Initiates file downloadRT-PLUS MODULAR FEMORAL BLOCK