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

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    QUANTIMETRIC PLUS SUPPORT PACK

    FDA 510(k)
    FDA Class 2 ·Immunology

    PowerBar

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746164774·FIXED FUNCT POWERBAR CLASS II 13MM UNIV 2/PK

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209136957·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837012038·

    ARx

    FDA UDI
    Life Spine, Inc.·00190837135553·

    Arx

    FDA UDI
    Life Spine, Inc.·00190837075347·Polyaxial Non-Cannulated Screw, 8.5x50mm

    Arx

    FDA UDI
    Life Spine, Inc.·00190837125868·

    SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO

    FDA 510(k)
    FDA Class 1 ·Hematology

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 9, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 5, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 3, 2012

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017