BEUDAMED
    171 results · 49ms · Sources: EU EUDAMED, US FDA
    Filters FDA Pre Market Approval ×

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·PreVue Pre-loaded System, IPURE Pre-loaded System

    FDA Pre-Market Approval
    TOUCH® CMC 1 Prosthesis

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System

    FDA Pre-Market Approval
    PRE OP SPONGE

    Prosthesis, Posterior Spinal Elements

    FDA Pre-Market Approval
    FDA Class 3 ·TOPS™ System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·PreVue Pre-Loaded System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·MYCARELINK PATIENT MONITOR, MYCARELINK READER FRU

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·COSEAL SURGICAL SEALANT (ORIGINAL AND PRE-MIXED)

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·R1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER

    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

    FDA Pre-Market Approval
    FDA Class 3 ·AAV5 DetectCDx®

    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

    FDA Pre-Market Approval
    FDA Class 3 ·AAV5 DetectCDx

    Prosthesis, Posterior Spinal Elements

    FDA Pre-Market Approval
    FDA Class 3 ·TOPS™ System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF IQ TORIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·HOYA iSert 250/251 and Clarisert Pre-Loaded IOL Injector System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System