BEUDAMED
    8 results · 27ms · 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 ×

    ADAMS BREAST IMPLANT PROTECTOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BETA THALQUIK COLUMN #5341

    FDA 510(k)
    FDA Class 2 ·Hematology

    KNEE WALKER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    POWERFLEX EXTREME PTA DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code LIT·June 25, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 2, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 1, 2010

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·May 21, 2014