BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    Zone Specific AIM

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

    LUMEX

    FDA UDI
    GF HEALTH PRODUCTS, INC.·M36882201861·W/C CUSHIONGEL/FOAM18X16X4

    TrueRelief Device

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONMED SYSTEM 5000 ESU

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

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·May 26, 2021

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·November 3, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·August 16, 2011

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    ALINITY I B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code CDD·May 14, 2021

    LAPIPLASTY SYSTEM S4A

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 2025

    Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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