BEUDAMED
    10 results · 31ms · Sources: EU EUDAMED, US FDA

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    Biomate Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    SYRINGE 10CC S/T WOS STERILE WATER BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 10, 2021

    FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BCI AUTOCON 3304 DIGITAL PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD PLASTIPAK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMI·March 18, 2019

    NEU_ENTERRA_INS

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LNQ·October 18, 2017

    MESH- COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC·Product code FTL·July 12, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 14, 2013

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·August 22, 2018