BEUDAMED
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    THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694088381·Micro Safety Screw, 1.5mm x 2mm

    Otomag™ Alpha 2 Sound Processor

    FDA UDI
    MEDTRONIC XOMED, INC.·00643169799844·PROCSR S0415-02 ALPH2LP AN MRI COND ROHS

    Otomag™ Alpha 2 Sound Processor

    FDA UDI
    MEDTRONIC XOMED, INC.·00643169671515·PROCSR S0415-02 ALPH 2 LOPRO AN MRI UNSF

    Otomag™ Alpha 2 Sound Processor

    FDA UDI
    MEDTRONIC XOMED, INC.·00643169644588·PROCESSOR S0415-02 ALPHA2MPO AN MRI COND

    Otomag™ Alpha 2 Sound Processor

    FDA UDI
    MEDTRONIC XOMED, INC.·00643169645288·PROCESSOR S0415-02 ALPHA2MPO AN MRI UNSF

    Otomag™ Alpha 2 Sound Processor

    FDA UDI
    MEDTRONIC XOMED, INC.·00643169671522·PROCSR S0415-02 ALPH 2 LOPRO AN MRI COND

    zumax

    FDA UDI
    Zumax Medical Co., LTD·06945095526681·

    CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 15, 2024

    Optimotion Blue CR HCCR Total Knee System

    FDA UDI
    OPTIMOTION IMPLANTS LLC·B6961014P0415020·CR Tibial Insert, UHMWPE + Vitamin E, Size 4, ...

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·April 6, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 8, 2013

    VITALITY AVT FAST-CHARGE

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013