BEUDAMED
    13 results · 20ms · 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 ×

    ELTA ADVANCED WOUND WASH

    FDA 510(k)
    FDA Unclassified ·Unknown

    Cook

    FDA UDI
    COOK INCORPORATED·00827002145672·Fascial TFE Dilator

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981286200·Offset Lipped Posterior Retractor Blade, 100mm

    HDL-CHOLESTEROL PLUS 2ND GENERATION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PERIFIX SAFETY EPIDURAL NEEDLES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 23, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 27, 2011

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 7, 2018

    14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 7, 2018

    Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 7, 2018

    Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 4, 2018

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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