BEUDAMED
    3,100 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·FlexNav™ and Navitor Loading System, FlexNav™ Delivery System

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Ranger™ Paclitaxel-Coated PTA Balloon Catheter

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL

    Stent, Coronary

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

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·HERCEPTEST

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·VYSIS PATH VYSION HER-2 DNA PROBE KIT

    Bronchial Thermoplasty System

    FDA Pre-Market Approval
    FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·VNS THERAPY SYSTEM

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·SMARTFREEZETM Catheter Extension Cable

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Simplify® Cervical Artificial Disc (One-Level)

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED®) System

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·Hydrus® Microstent

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·OVATIO CRT-D SYSTEM

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 28-8 pharmDx