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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    CPRmeter 2 CPR Feedback Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMED Mesh Nebulizer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PERSEUS A500

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 17, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 24, 2011

    QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 15, 2014

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012