BEUDAMED
    5,527 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·VERIFLEX CORONARY STENT SYSTEM (MONORAIL)

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Trifecta™ and Trifecta™ Valve with Glide Technology (Trifecta™ GT) valves

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

    Stent, Central Venous

    FDA Pre-Market Approval
    FDA Class 3 ·WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

    Stent, Renal

    FDA Pre-Market Approval
    FDA Class 3 ·EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO ICDS/MAXIMO II CRT-D/SECURA FAMILY ICD

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·BOND Oracle HER2 IHC System

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·MOSAIC PORCINE BIOPROSTHETIC

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·DEMA IPG/DDDR/CLARITY SSIR/DIAMOND III/RUBY III/TOPAZ III/JADE III/VITA 2 DDDR

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·SVC/CS TRANSVENE LEAD

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Inspiris Resilia Aortic Valve

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS- (MODELS T505, T510)

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas KRAS Mutation Test

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Hancock II Porcine Bioprosthesis