BEUDAMED
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    UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FRYE & CO

    FDA UDI
    FGX INTERNATIONAL INC.·00193033483022·

    D7-2 Ultrasonic Probe(FDA)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06936415911669·

    Brisbane Trial Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215044213·

    SYNVITRO FLUSH

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BONE PLATE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·February 26, 2015

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·March 1, 2013

    ASR ACETABULAR IMPLANT 64

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·February 24, 2011

    3M 1870 HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK

    FDA Adverse Event
    Injury ·3M HEALTH CARE·Product code FXX·March 12, 2008

    BONE PLATE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·February 26, 2015

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 5, 2022

    BONE PLATE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·February 26, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·February 26, 2015

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016