BEUDAMED
    681 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·DAKO HERCEPTEST

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QuantiFERON TB Gold Test, QuantiFERON TB Gold Test (reference lab pack), QuantiFERON TB Gold Plus Test, QuantiFERON TB G

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

    FDA Pre-Market Approval
    FDA Class 3 ·HER2 FISH PHARMADX KIT

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

    Implanted Brain Stimulator For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NEUROPACE RNS SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·MEMORYGEL BREAST IMPLANT

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COLOGUARD

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC AT500 DDDRP PACING SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·COFLEX INTERLAMINAR TECHNOLOGY

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS TORIC 1-PIECE INTRAOCULAR LENS

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·COROX OTW STEROID LV LEAD MONITORING (COSMO)

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·PRESTIGE LP Cervical Disc

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF IQ TORIC INTAOCULAR LENS

    Filler, Bone Void, Synthetic Peptide

    FDA Pre-Market Approval
    FDA Class 3 ·AUGMENT BONE GRAFT

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

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

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·ARTEFILL