BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    Advanced Gynecological Applicator

    FDA 510(k)
    FDA Class 2 ·Radiology

    Oticon

    FDA UDI
    Oticon A/S·05707131305404·SENSEI, BTE 13 WL 90 PUW

    EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ANTI-SNORING / SLEEP APNEA DEVICE

    FDA 510(k)
    FDA Class 2 ·Dental

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013

    UNKNOWN TRIDENT CERAMIC ACETABULAR SYSTEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·July 7, 2011

    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