BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    ControlSeal Electrode (ELSB)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ASO Speed Lacer Ankle Stabilizer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357236053·

    SMARTFLOW CATHETER

    FDA 510(k)
    FDA Class 2 ·Neurology

    SteriTrak

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RIATA ACTIVE FIXATION

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

    CAPTURE-R READY SCREEN I AND II

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·August 25, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·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