BEUDAMED
    171 results · 28ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·BIOLECTRON ORTHO-PAK BONE GROWTH STIMULATOR/SPINALPAK SPINAL FUSION STIMULATOR

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC CAPSURE SP NOVUS MODEL 4092 VITATRON EXCELLENCE PS+ MODEL IMK 49B TRANVENOUS VENTRICULAR LEAD

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Proclaim DRG Systems

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim DRG Implant

    Tissue Adhesive For Internal Use

    FDA Pre-Market Approval
    FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Dorsal Root Ganglion (DRG) External Pulse Generator (EPG)

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·DRG Small/Big Curve Delivery Sheath Kit, 22cm; DRG Lead Accessories Kit; SlimTip DRG Trial Lead Kit, 50cm and 90cm; Slim

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Dorsal Root Ganglion (DRG) Stimulation

    Dorsal Root Ganglion Stimulator For Pain Relief

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

    Dorsal Root Ganglion Stimulator For Pain Relief

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

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Proclaim DRG IPG

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Proclaim DRG IPG Clinical Programmer App