BEUDAMED
    673 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SK15 AND SK16

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·NUVASIVE PCM CERVICAL DISC SYSTEM

    Tester, Acoustic, Bone Quality

    FDA Pre-Market Approval
    FDA Class 3 ·QUS-2 (TM) CALCANEAL ULTRASONOMETER

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·RITHRON-XR CORONARY STENT SYSTEM

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4

    Laparoscopic Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·META-MV,PACING SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HEARTMATE VE LVAS

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    FDA Pre-Market Approval
    FDA Class 3 ·CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·COSEAL SURGICAL SEALANT (COSEAL)

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·EVOLENCE COLLAGEN FILLER

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·UROLUME ENDOPROSTHESIS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

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

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT HBE DIAGNOSTIC KIT

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·HEALTHTRONICS OSSATRON

    Kit, Assay, Estrogen Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ER-ICA MONOCLONAL

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·VIDAS TPSA ASSAY

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·CHILLI COOLED RF ABLATION SYSTEM

    Catheter, Balloon For Retinal Reattachment

    FDA Pre-Market Approval
    FDA Class 3 ·LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER