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

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    Neuronaute with IceCap 2 & IceCap 2 Small

    FDA 510(k)
    FDA Class 2 ·Neurology

    ASO Speed Lacer II Ankle Stabilizer w/Stays

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357236442·

    MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIZION + DR

    FDA 510(k)
    FDA Class 2 ·Radiology

    TENDRIL ST

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

    PRISM HTLV-I/HTLV-II

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MTP·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

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

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