BEUDAMED
    17 results · 39ms · Sources: EU EUDAMED, US FDA

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    DIGIFIX EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY

    FDA 510(k)
    FDA Unclassified ·Unknown

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 20, 2015

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 29, 2016

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 24, 2016

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    CORMET RESURFACING

    FDA Adverse Event
    CORIN LTD.·Product code NXT·May 23, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 21, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 17, 2011

    THERMAGE CPT SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020

    THERMAGE CPT SYSTEM TIP

    FDA Adverse Event
    Injury ·SOLTA MEDICAL INC·Product code GEI·November 30, 2022

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019