BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

    FDA 510(k)
    FDA Class 2 ·Neurology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517569929·CoRoent Ant TLIF Ti, 12x13x28mm 8°

    COBRA BIPOLAR CLAMP, MODEL 15902

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HEMOCONCENTRATOR

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

    HEMOCONCENTRATOR BC 20 PLUS

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code KDI·April 1, 2016

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·August 25, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018