7,246 results
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43ms
·
Sources: EU EUDAMED, US FDA
TECA PREMIERE
FDA 510(k)
FDA Class 2
·Neurology
DG PORTABLE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
TEMPUS PRO WITH ENHANCED FEATURES
FDA 510(k)
FDA Class 2
·Cardiovascular
Tempus IC2
FDA 510(k)
FDA Class 2
·Cardiovascular
ARCHITECT
FDA UDI
ABBOTT LABORATORIES·00380740001780·ARCHITECT iPhenobarbital Reagent Kit
ARCHITECT
FDA UDI
ABBOTT LABORATORIES·00380740001773·ARCHITECT iPhenobarbital Calibrators
Computer-Assisted Personalized Sedation System
FDA Pre-Market Approval
FDA Class 3
·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Philips HeartStart FR3 Defibrillator
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
Lens, Contact (Other Material) - Daily
FDA Pre-Market Approval
FDA Class 2
·BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·VASCULAR SOLUTION DUETT SEALING DEVICE
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger
10 ml Z No Additive Blood Collection Tube
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device
9 ml Z No Additive Blood Collection Tube
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device
6 ml Z No Additive Blood Collection Tube
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device
5 ml Z No Additive Blood Collection Tube
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device
2 ml Z No Additive Blood Collection Tube
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device
4 ml Z No Additive Blood Collection Tube
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
FDA Pre-Market Approval
FDA Class 3
·LCS(R)TOTAL KNEE SYSTEM