BEUDAMED
    3,124 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

    FDA Pre-Market Approval
    FDA Class 3 ·Cartiva SCI reusable instrumentation

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)

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

    FDA Pre-Market Approval
    FDA Class 3 ·OSTEONICS ABC SYSTEM AND TRIDENT SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Pearl Vision Monthly (confilcon A) Soft (Hydriohilic) Contact Lenses , Pearle Vision Monthly for Astigmatism (comfilcon

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·PROMOTE ACCEL CRT-D

    Bronchial Thermoplasty System

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

    Stent, Renal

    FDA Pre-Market Approval
    FDA Class 3 ·FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·SCULPTRA AESTHETIC

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·Genesys HTA System

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·RESONATE™ HF, RESONATE™ EL, MOMENTUM™ EL, VIGILIANT™ EL, PERCIVA™ HF, PERCIVA™

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE

    Stent Graft, Bypass, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·DETOUR System

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·R3 Delta Ceramic Hip System

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 3000, 3100, 4000.

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

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR MEMORYGEL SILICONE-FILLED BREAST IMPLANT

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM