BEUDAMED
    10 results · 28ms · 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.

    S-FILE, S-FINDER, S-ENGINE FILE

    FDA 510(k)
    FDA Class 1 ·Dental

    Vyaire

    FDA UDI
    Jaeger Medical GmbH·34250892904352·Mouthpiece

    Jaeger

    FDA UDI
    Jaeger Medical GmbH·34250892907360·Disposable Mouthpiece, flex

    Jaeger

    FDA UDI
    Jaeger Medical GmbH·34250892900897·Mouthpiece

    Vita Flex CR System with LLI

    FDA 510(k)
    FDA Class 2 ·Radiology

    EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·June 24, 2014

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·November 8, 2010

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 28, 2012

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015