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

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    Dreem 3S

    FDA 510(k)
    FDA Class 2 ·Neurology

    STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 4, 2024

    JUVEDERM VOLUMA WITH LIDOCAINE 1 ML

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·October 29, 2014

    AMBULIFT

    FDA Adverse Event
    Malfunction ·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·July 22, 2011

    A1CNOW SELFCHECK

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code LCP·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