BEUDAMED
    10,000 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Pre Market Approval ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer Open-Irrigated Ablation Catheter

    Enzyme Immunoassay, Tracrolimus

    FDA Pre-Market Approval
    FDA Class 2 ·IMX TACROLIMUS II ASSAY

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CORDIS SEQUICOR THETA MODELS 233D & 233E

    Single-Use Internal Condom

    FDA Pre-Market Approval
    FDA Class 2 ·FC2 FEMALE CONDOM

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT ANTI-HCV

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·FLEXSOL

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·BIOTRONIK ICD FAMILIES

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGICEL

    Implanted Brain Stimulator For Epilepsy

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

    FDA Pre-Market Approval
    PROTECTA/PROTECTA XT CRT-DS

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·ITREL 3, SYNERGY, SYNERGY VERSITREL, ITREL, POCKET ADAPTOR

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·GORE CARDIOFORM Septal Occluder

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·CERAMAX Ceramic Total Hip System