BEUDAMED
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    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PREVELEAK SURGICAL SEALANT

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Cordis® EXOSEAL® Vascular Closure Device

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC VAD SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOFINITY CONTACT LENSES

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ADDVENT/AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY/ZEPHYR/ACCENT/TRILOGY/SYNCHRONY/PARAGONPHOENIX

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RESTYLANE INJECTABLE GEL

    Shunt, Portosystemic, Endoprosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIATORR TIPSEndoprosthesis product family

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Coronary Stent System

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·ORBERA INTRAGASTRIC BALLOON SYSTEM

    Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

    FDA Pre-Market Approval
    FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM FREE PSA

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Orsiro Sirolimus Eluting Coronary Stent System

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·PRESTIGE(R) LP CERVICAL DISC

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS Total Knee System

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

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

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE Skypoint Everolimus Eluting Coronary Stent System

    Automated Breast Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·Invenia ABUS (Automated Breast Ultrasound System) 2.0