BEUDAMED
    10,000 results · 43ms · Sources: EU EUDAMED, US FDA

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Lap-Band Adjustable Gastric Banding System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·TENDRIL FAMILY F LOW VOLTAGE LEADS

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Tridyne Vascular Sealant

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

    FDA Pre-Market Approval
    FDA Class 3 ·Corox OTW BP

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 22C3 PharmDx

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® CARDIOFORM ASD Occluder

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE DEVICE

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·MYNXGRIP VASCULAR CLOSURE DEVICE (5F, 6F/7F)

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·CLEARSOFT (METHAFILCON A) SOFT COTACT LENS

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

    FDA Pre-Market Approval
    FDA Class 3 ·BLAZER II XP CATHETERS

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx (F1CDx)

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Systems

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS

    Prosthesis, Intervertebral Disc

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

    Glenoid Fossa Prosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM