BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    Respiratory Muscle Trainer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MENTOR GENESIS PENILE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    COCR HEAD 28/+4 'L' 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code MEH·January 26, 2026

    SAMSUNG GALAXY WATCH 5 PRO (Z9NL)

    FDA Adverse Event
    Malfunction ·SAMSUNG ELECTRONICS AMERICA, INC.·Product code QDA·May 26, 2026

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·November 10, 2014

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·August 17, 2011

    TOTALCARE BARIATRIC BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·July 17, 2013

    PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code LPH·October 17, 2025

    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

    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