BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    LifeShield™ Infusion Safety Software Suite

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASO Speed Lacer Ankle Stabilizer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357236060·

    TILITE YG AND TILITE YGS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE

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

    NEXXT MATRIXX® Stand Alone ALIF System

    FDA UDI
    NEXXT SPINE, LLC·00889929069745·Coronal SA ALIF, 22Dx36Wx6H 18°x04°

    RIATA ACTIVE FIXATION

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

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    FLEXTEND

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·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

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026