BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    LED Lip Perfector, model: ZC-05

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ASO Speed Lacer II Ankle Stabilizer w/Stays

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357236428·

    MUSCLE STIMULATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PICCOLO TOTAL CHOLESTEROL TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PRISM HTLV-I/HTLV-II

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MTP·August 25, 2011

    MICRO INCISION VACUUM PACK

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·August 5, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·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

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

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