BEUDAMED
    25 results · 29ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors

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

    FDA Pre-Market Approval
    FDA Class 3 ·PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·MECHANICAL HEART VALVE SJM(R) MASTER SERIES (EXPANDED SEWING CUFF)

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE

    Aspiration Therapy System

    FDA Pre-Market Approval
    FDA Class 3 ·AspireAssist

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·MECHANICAL HEART VALVE, MASTERS SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-514 00

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters

    Lithotripter, Shockwave (For Treating Gallbladder Stones)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDSTONE STS LITHOTRIPTER

    Lithotripter, Shockwave (For Treating Gallbladder Stones)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDSTONE STS LITHOTRIPTER

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)

    Lithotripter, Shockwave (For Treating Gallbladder Stones)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDSTONE STS-TC/U LITHOTRIPTER

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·BD Onclarity™ HPV Assay

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·BD Onclarity HPV Assay

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·BD Onclarity HPV Assay