JULIJ

Datum Klasifikacijski znak JAZMP Proizvajalec Medicinski pripomoček
20.06.2019 301-79/2019 Roche Diagnostics GmbH, DE Initiates file downloadBILD2 (Bilirubin direct Gen.2) - Posodobljeno varnostno obvestilo
21.06.2019 301-78/2019 Ethicon Endo Surgery (Europe) GmbH, DE Initiates file downloadIntraluminal Staplers (ILS) ECS21A, ECS25A, ECS29A, ECS33A, CDH21A, CDH25A, CDH29A, CDH33A - Posodobljeno varnostno obvestilo
21.06.2019 301-286/2018 GE Healthcare, ZDA Initiates file downloadCT-scanners (with exception of the type 'Revolution CT'), PET-CT applications and SPECT-CT applications
02.07.2019 301-179/2019 Dexcom, Inc., ZDA Initiates file downloadDexcom G4 PLATINUM, Dexcom G5 Mobile
03.07.2019 301-209/2019 SAMSUNG MEDISON CO., LTD., KR Initiates file downloadWS80A, HS70A
03.07.2019 301-180/2019 Roche Diagnostics GmbH, DE Initiates file downloadElecsys Anti-CCP cobas e 411 / 601/ 602/ 801 Modular Analytics E170
03.07.2019 301-181/2019 HERDEGEN SAS, FR Initiates file downloadElbow crutch Advance bi matière
04.07.2019 301-182/2019 Elekta, Inc., ZDA Initiates file downloadMonaco RTP System
08.07.2019 301-185/2019 Zimmer, Inc, ZDA Pulsavac® Plus Wound Debridement System Initiates file download Obvestilo 1, Initiates file downloadObvestilo 2
08.07.2019 301-186/2019 Smiths Medical ASD, Inc., ZDA Deltec GRIPPER Needle Initiates file download Obvestilo 1, Initiates file downloadPriloga
08.07.2019 301-187/2019 Electromedical Products International, Inc, ZDA Initiates file downloadAlpha Conducting Solution
11.07.2019 301-188/2019 Leonhard Lang GmbH, AT Initiates file downloadGS CORPATCH EASY PRE-CONNECTED
11.07.2019 301-189/2019 Laboratoire ENDALIS, FR Initiates file downloadEnd Ball ENDT110
11.07.2019 301-190/2019 TECHNO CONCEPT, FR Initiates file downloadVIBRAMOOV
12.07.2019 301-191/2019 Roche Diagnostics GmbH, DE Initiates file downloadONLINE TDM Vancomycin Gen.3 (VANC3)
16.07.2019 301-192/2019 Medical Intelligence Medizintechnik GmbH, DE Initiates file downloadHexaPOD evo RT System
16.07.2019 301-184/2019 MESI, razvoj medicinskih naprav, d.o.o. SI Initiates file downloadABPIMDD
17.07.2019 301-110/2019 Philips Medical Systems, ZDA Initiates file downloadIntelliVue MX40 Patient Monitor ; 865350, 865351, 865352, 857146 / N/A / N/A - Posodobljeno varnostno obvestilo
18.07.2019 301-194/2019 Siemens Healthcare Diagnostics Products Limited, GB Initiates file downloadIMMULITE/IMMULITE 1000 Progesterone
19.07.2019 301-149/2019 Philips Medical Systems, ZDA Initiates file downloadheartStart MRx Defibrillator/Monitor - Posodobljeno varnostno obvestilo
19.07.2019 301-195/2019 Bio-Rad Laboratories, FR Initiates file downloadPlatelia Toxo IgA TMB
22.07.2019 301-196/2019 Philips Medical Systems,ZDA Initiates file downloadIngenuity CT, Ingenuity Core, Ingenuity Core 128, Brilliance 64, IQon Spectral CT, iCT, iCT SPCT, Ingenuity TF PET/CT, Vereos PET/CT
23.07.2019 301-198/2019 Randox Laboratories Ltd, GB Initiates file downloadCallbration Serum Level 3
24.07.2019 301-199/2019 Medisoft S.A., BE Initiates file downloadFeNO+
24.07.2019 301-200/2019 JOLIFE AB, SE (Stryker) Initiates file downloadLUCAS 2 CHEST COMPRESSION SYSTEM
29.07.2019 301-202/2019 Siemens Healthcare Diagnostics Limited, ZDA Initiates file downloadADVIA Centaur Folate
30.07.2019 301-169/2019 Philips Healthcare, ZDA Initiates file downloadBrightView, BrightView X, BrightView XCT - Posodobljeno varnostno obvestilo
31.07.2019 301-204/2019 Cell Marque Corporation, ZDA Initiates file downloadKAPPA (EP171) RABBIT MONOCLONAL PRIMARY ANTIBODY