BEUDAMED
    374 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·SPRINT QUATTRO SECURE LEADS MODELS 6935 & 6947

    Shockwave Intravascular Lithotripsy System

    FDA Pre-Market Approval
    FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT™ Admiral™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Stellarex 035 OTW Drug-Coated Angiopiasty Balloon (DCB)

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB)

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB)

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT Admiral DCB Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·SurVeil Drug-Coated Balloon

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LUTONIX DRUG COATED BALLOON PTA CATETER

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon Catheter