BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    Vitrea Software Package, VSTP-002A

    FDA 510(k)
    FDA Class 2 ·Radiology

    Wrist Lacer II

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357233366·

    OCO DENTAL IMPLANT (5.0MM DIAMETER)

    FDA 510(k)
    FDA Class 2 ·Dental

    Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 4, 2014

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·August 15, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025