BEUDAMED
    9 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.
    Filters Regulation: Us FDA ×

    MARK I & II TOTAL KNEE REPLACE. SYS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    YALE NH TT VISION SYS GBS

    FDA Adverse Event
    Other ·GISH BIOMEDICAL, INC.·Product code OEZ·December 3, 2010

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·May 23, 2014

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 13, 2012

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010

    B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018