BEUDAMED
    10,000 results · 44ms · Sources: EU EUDAMED, US FDA

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella Ventricular Support Systems

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·ENROUTE Transcarotid Stent System

    Absorbable Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Axium Neurostimulator System

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Telemetry Wand

    Catheter, Coronary, Atherectomy

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

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE LEAD,CAPSURE SP LEAD,VITATRON CRYSTALINE LEAD,VITATRON EXCELLENCE PS+LEAD

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM (VCS)

    Transcervical Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·ESSURE CONTRACEPTIVE TUBAL OCCLUSION DEVICE AND DELIVERY SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR

    Stent, Renal

    FDA Pre-Market Approval
    FDA Class 3 ·EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF IQ RESTOR APODIZED + 3.0D MULTIFOCAL TORIC INTRAOCULAR LENS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIRTRAKS Clinical Study

    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Ascension MCP

    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

    FDA Pre-Market Approval
    FDA Class 3 ·TMX-2000 BPH

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·AT500 DDDRP PACING SYSTEM (MODEL AT500) AND MODEL 9968 SOFTWARE POST-MARKET (RESPECT): ADDING THE ENRHYTHM MODEL P1501DR