BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    CELESTEION, PCA-9000A/2

    FDA 510(k)
    FDA Class 2 ·Radiology

    REMINGTON I-LIGHT HAIR REMOVAL SYSTEM

    FDA Adverse Event
    Injury ·SHASER INC·Product code ONF·May 21, 2021

    STABILIZ FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 28, 2026

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·May 31, 2013

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008

    HEART START XL

    FDA Adverse Event
    Malfunction ·AGILENT TECHNOLOGIES, INC·Product code MKJ·June 17, 2011

    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