BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    PHENYTOIN FPIA CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    NA

    FDA UDI
    STERILMED, INC.·10888551007665·SAW BLADE OSCILLATING LARGE BONE

    AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IRIX-A Lumbar Integrated Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLOEY CATHETER W TEMP

    FDA Adverse Event
    Injury ·DEGANIA SILICONE LTD·Product code DRF·October 17, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·DEGANIA SILICONE LTD.·Product code KOD·July 7, 2017

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 15, 2010

    ASR ACETABULAR CUP 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 13, 2012

    FOLEY CATHETER W TEMP

    FDA Adverse Event
    Malfunction ·MMJ SA DE CV (USD)·Product code DRF·November 9, 2018

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015