BEUDAMED
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    Quantisal™ II Oral Fluid Collection Device

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ryno Lacer Wrist and Thumb Support

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357237814·

    BD Difco™ FA Bordetella Parapertussis Antiserum

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902237815·Vial Fa Bordetella Parapertus 5Ml

    TRANSTEK GLASS BODY FAT ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·November 4, 2014

    OT ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·August 25, 2011

    DUROM ACETABULAR COMPONENT 54/48 CODE N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·July 10, 2013

    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