December

DatumKlasifikacijski znak JAZMPProizvajalecMedicinski pripomoček
02.12.2019301-303/2019Thoratec Corporation, ZDAHeartMate 3™ Left Ventricular Assist System
(Mobile Power Unit™)
02.12.2019301-304/2019Thoratec Corporation, ZDAHeartMate 3™ Left Ventricular Assist System
 (Modular Cables)
03.12.2019301-305/2019MICROVENTION INC., ZDADetachable Azur Peripheral Coil System
05.12.2019301-306/2019ResMed Ltd, AUStellar 100/ Stellar 150
05.12.2019301-307/2019AMO Uppsala AB, SEHealon GV® PRO
09.12.2019301-309/2019Gebrüder Martin GmbH & Co. KG – KLS
Martin Group, DE
Skalpellklinge, Fig. 15, REZILO ZA SKALPEL, sterilno
09.12.2019301-310/2019MicroVention Inc., ZDAHydroCoil Embolic System (HES) and MicroPlex Coil System (MCS)
10.12.2019301-311/2019CapsoVision, Inc., ZDACapsoCam Plus (SV-3)
10.12.2019301-312/2019Abbott Diagnostics Technologies AS, NONycoCard D-Dimer
12.12.2019301-223/2019Roche Diagnostics GmbH, DEALB2 (Albumin Gen.2), BILT3 (Bilirubin Total Gen.3)
Posodobljeno varnostno obvestilo
12.12.2019301-11/2018PACIFIC MEDICO, JPPMH 7000 Series
Posodobljeno varnostno obvestilo
12.12.2019301-313/2019MAQUET SAS, FRSterilizable handle “Hanaulux”
16.12.2019301-314/2019Edwards Lifesciences LLC, ZDAQuickdraw – Peripheral venous access cannula
17.12.2019301-315/2019Biomet France, FR
BIOMET Orthopaedics Switzerland GmbH, CH
OPTIPAC Orthopedic cement
Obvestilo 1Obvestilo 2
17.12.2019301-316/2019Randox Laboratories Ltd, GBRX Daytona
Obvestilo 1Priloga
17.12.2019301-317/2019VitreQ B.V., NLVitreQ
17.12.2019301-318/2019Datex-Ohmeda, Inc, ZDACarestation 600 Series
18.12.2019301-319/2019TESCOM EUROPE GMBH & CO. KG, DEWegaMed
18.12.2019301-320/2019Aesculap AG, DECAIMAN EINM.INSTR.ABWINKELB.D:12/240MM
18.12.2019301-321/2019MedtronicClaria 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
18.12.2019301-322/2019Respironics, Inc., ZDATrilogy Evo, Garbin Evo, LifeVent Evo2
19.12.2019301-323/2019Argon Medical Devices, Inc., ZDAWORKER™ Amplatz Guidewires
19.12.2019301-324/2019KARL STORZ SE & Co. KG, DEAutocon
19.12.2019301-325/2019W.L. Gore & Associates, Inc. Medical Products Division, ZDAGORE® EXCLUDER® AAA Endoprosthesis & GORE IBE
Obvestilo 1Priloga
19.12.2019301-326/2019Fast-Track Diagnostics S.a.r.l., LUFTD Respiratory pathogens 21
19.12.2019301-327/2019Covidien Ilc, ZDAPolysorb Braided Absorbable Suture, Biosyn Absorbable Suture
20.12.2019301-328/2019Medartis AG, CH2.5 Trilock Screw 14mm, HD7
20.12.2019301-329/2019SCHILLER AG, CHTempus LS
23.12.2019301-330/2019Datex-Ohmeda, Inc, ZDAGiraffe Omnibed, Giraffe Incubator, Giraffe Omnibed Carestation,
Giraffe Incubator Carestation
Obvestilo 1Obvestilo 2
23.12.2019301-331/2019KARL STORZ SE & Co. KG, DEInsufflation Tubing Set, with gas filter
30.12.2019301-332/2019Siemens Healthcare Diagnostics Inc, ZDAEnzymatic Creatinine Rgt
Obvestilo 1Obvestilo 2Obvestilo 3Obvestilo 4
30.12.2019301-333/2019Siemens Healthcare Diagnostics Inc, ZDAADVIA Chemistry Lipase Reagents (LIP)
30.12.2019301-334/2019Mavidon MedicalLemonPrep® Tubes, Single use cups PediaPrep® Tubes, Single use cups Wave Prep® Tubes, Single use cups Cardio Prep Single use cups
31.12.2019301-335/2019SCHILLER Medical, FRDEFIGARD Touch7
31.12.2019301-281/2019TORNIER SAS, FranceAequalis Ascend Flex Shoulder System
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