BEUDAMED
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    GEM Premier 7000 with IQM3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Accu-Chek FastClix Blood Lancing System

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

    ENDO E CLASS

    FDA 510(k)
    FDA Class 1 ·Dental

    NEXXT MATRIXX® Stand Alone ALIF System

    FDA UDI
    NEXXT SPINE, LLC·00889929069752·Coronal SA ALIF, 22Dx36Wx8H 18°x04°

    ROTATABLE SNARE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FDI·August 25, 2011

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 5, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·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