BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    HybridTherm System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257142622·30-40 MFW VITALITY CALF CT CHOC II

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257126073·30-40 MV FOR MEN CLSC CALF STD BRN II

    EASYNET BODY POSITION MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    AMSEL OCCLUDER DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYNERGY

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·November 10, 2014

    HEMOPRO2 EXTENSION CABLE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 17, 2011

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code HET·July 22, 2013

    IMP,TSV,4.1,10,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 17, 2021

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014