BEUDAMED
    9 results · 41ms · Sources: EU EUDAMED, US FDA

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    INFANT HEEL WARMER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Freedom Cementless Femoral Component

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYSTEM 98XT

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP·Product code DSP·June 6, 2014

    STAR S4-IR-ETL EXCIMER LASER

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code LZS·February 8, 2013

    LASIK

    FDA Adverse Event
    Injury ·Product code LZS·December 29, 2010

    4.5MM LCP® PROXIMAL FEMUR HOOK PLATE 6 HOLES/205MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·September 10, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·September 10, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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