BEUDAMED
    3,122 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY™ XD Everolimus-Eluting Platinum Chromium Co

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra TPS

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP

    Transcervical Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·Essure System for Permanent Birth Control (Model ESS305)

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM (SUPERB)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR XP PSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·PARADYM VR 8250, PARADYM DR 8550, PARADYM CRT-D 8750, PARADYM RF VR 9250, PARADYM RF DR 9550, PARADYM M RF CRT-D 9750

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATIONS SOFTWARE

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·COFLEX® INTERLAMINAR TECHNOLOGY

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Spatz3 Adjustable Balloon System

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    FDA Pre-Market Approval
    FDA Class 3 ·Sphere-9 Catheter and Affera Ablation System

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Avive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·IDENTITY, INTEGRITY, VERITY, VICTORY, AND ZEPHYR FAMILIES OF PACEMAKERS