BEUDAMED
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    CONGRUENT BONE PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. Intended use: Cutting Bones

    FDA Recall
    Terminated ·Acumed LLC·Product code HRS·April 14, 2010

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441701·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441688·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033441695·

    AT HOME DRUG TESTT, MODEL 9150 T

    FDA 510(k)
    FDA Unclassified ·Unknown

    DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KUFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 22, 2013

    PINN SECTOR W/GRIPTION 64MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 24, 2011

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·March 11, 2008

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

    SIMULUS SEMI-RIGID ANNULOPASTY RING

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2020

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 20, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 9, 2025