BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    LIO-714 OPACITYMETER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code CAW·May 5, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 15, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 31, 2007

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021