December

Datum Klasifikacijski znak JAZMP Proizvajalec Medicinski pripomoček
02.12.2019 301-303/2019 Thoratec Corporation, ZDA Initiates file downloadHeartMate 3™ Left Ventricular Assist System
(Mobile Power Unit™)
02.12.2019 301-304/2019 Thoratec Corporation, ZDA Initiates file downloadHeartMate 3™ Left Ventricular Assist System
 (Modular Cables)
03.12.2019 301-305/2019 MICROVENTION INC., ZDA Initiates file downloadDetachable Azur Peripheral Coil System
05.12.2019 301-306/2019 ResMed Ltd, AU Initiates file downloadStellar 100/ Stellar 150
05.12.2019 301-307/2019 AMO Uppsala AB, SE Initiates file downloadHealon GV® PRO
09.12.2019 301-309/2019 Gebrüder Martin GmbH & Co. KG - KLS
Martin Group, DE
Initiates file downloadSkalpellklinge, Fig. 15, REZILO ZA SKALPEL, sterilno
09.12.2019 301-310/2019 MicroVention Inc., ZDA Initiates file downloadHydroCoil Embolic System (HES) and MicroPlex Coil System (MCS)
10.12.2019 301-311/2019 CapsoVision, Inc., ZDA Initiates file downloadCapsoCam Plus (SV-3)
10.12.2019 301-312/2019 Abbott Diagnostics Technologies AS, NO Initiates file downloadNycoCard D-Dimer
12.12.2019 301-223/2019 Roche Diagnostics GmbH, DE ALB2 (Albumin Gen.2), BILT3 (Bilirubin Total Gen.3)
Initiates file downloadPosodobljeno varnostno obvestilo
12.12.2019 301-11/2018 PACIFIC MEDICO, JP PMH 7000 Series
Initiates file downloadPosodobljeno varnostno obvestilo
12.12.2019 301-313/2019 MAQUET SAS, FR Initiates file downloadSterilizable handle "Hanaulux"
16.12.2019 301-314/2019 Edwards Lifesciences LLC, ZDA Initiates file downloadQuickdraw - Peripheral venous access cannula
17.12.2019 301-315/2019 Biomet France, FR
BIOMET Orthopaedics Switzerland GmbH, CH
OPTIPAC Orthopedic cement
Obvestilo 1, Obvestilo 2
17.12.2019 301-316/2019 Randox Laboratories Ltd, GB RX Daytona
Obvestilo 1, Priloga
17.12.2019 301-317/2019 VitreQ B.V., NL Initiates file downloadVitreQ
17.12.2019 301-318/2019 Datex-Ohmeda, Inc, ZDA Initiates file downloadCarestation 600 Series
18.12.2019 301-319/2019 TESCOM EUROPE GMBH & CO. KG, DE Initiates file downloadWegaMed
18.12.2019 301-320/2019 Aesculap AG, DE Initiates file downloadCAIMAN EINM.INSTR.ABWINKELB.D:12/240MM
18.12.2019 301-321/2019 Medtronic Initiates file downloadClaria MRI™/Amplia MRI™/Compia MRI™ CRT-Ds
 Viva™/Brava™ CRT-Ds
 Visia AF™/Visia AF MRI™ ICDs
Evera™/Evera MRI™/Primo MRI™/Mirro MRI™ ICDs
18.12.2019 301-322/2019 Respironics, Inc., ZDA Initiates file downloadTrilogy Evo, Garbin Evo, LifeVent Evo2
19.12.2019 301-323/2019 Argon Medical Devices, Inc., ZDA Initiates file downloadWORKER™ Amplatz Guidewires
19.12.2019 301-324/2019 KARL STORZ SE & Co. KG, DE Initiates file downloadAutocon
19.12.2019 301-325/2019 W.L. Gore & Associates, Inc. Medical Products Division, ZDA GORE® EXCLUDER® AAA Endoprosthesis & GORE IBE
Obvestilo 1, Priloga
19.12.2019 301-326/2019 Fast-Track Diagnostics S.a.r.l., LU Initiates file downloadFTD Respiratory pathogens 21
19.12.2019 301-327/2019 Covidien Ilc, ZDA Initiates file downloadPolysorb Braided Absorbable Suture, Biosyn Absorbable Suture
20.12.2019 301-328/2019 Medartis AG, CH Initiates file download2.5 Trilock Screw 14mm, HD7
20.12.2019 301-329/2019 SCHILLER AG, CH Initiates file downloadTempus LS
23.12.2019 301-330/2019 Datex-Ohmeda, Inc, ZDA Giraffe Omnibed, Giraffe Incubator, Giraffe Omnibed Carestation,
Giraffe Incubator Carestation
Obvestilo 1, Obvestilo 2
23.12.2019 301-331/2019 KARL STORZ SE & Co. KG, DE Initiates file downloadInsufflation Tubing Set, with gas filter
30.12.2019 301-332/2019 Siemens Healthcare Diagnostics Inc, ZDA Enzymatic Creatinine Rgt
Obvestilo 1, Obvestilo 2, Obvestilo 3, Obvestilo 4
30.12.2019 301-333/2019 Siemens Healthcare Diagnostics Inc, ZDA Initiates file downloadADVIA Chemistry Lipase Reagents (LIP)
30.12.2019 301-334/2019 Mavidon Medical Initiates file downloadLemonPrep® Tubes, Single use cups PediaPrep® Tubes, Single use cups Wave Prep® Tubes, Single use cups Cardio Prep Single use cups
31.12.2019 301-335/2019 SCHILLER Medical, FR Initiates file downloadDEFIGARD Touch7
31.12.2019 301-281/2019 TORNIER SAS, France Initiates file downloadAequalis Ascend Flex Shoulder System