BEUDAMED
    11 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.

    PACEMAKER, ELECTRODE, PERM. & TEMP.

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013998·OA Knee Brace, Single Upright, Right

    0800,IPS1,08,N,VL,U,AU,AT,RDL,SF

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828147811·0800,IPS1,08,N,VL,U,AU,AT,RDL,SF

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591014001·OA Knee Brace, Single Upright, Left

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306835407·Super Smooth Power Tip Injector 11G x 30cm 60cc

    DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI

    FDA 510(k)
    FDA Class 2 ·Radiology

    HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    UNKNOWN- UNSPECIFIED BY COMPLAINANT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code PAG·April 3, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·October 22, 2012

    SPINE REFERENCE CLAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·May 27, 2015

    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