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    SMISSON STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEE H10

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011

    COMPRESSIBLE LIMB SLEEVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALLERSHARP ALLERGY SKIN TESTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·March 26, 2013

    XPRT SLEEP SURFACE

    FDA Adverse Event
    Malfunction ·GAYMAR INDUSTRIES, INC.·Product code FNM·March 9, 2011

    ADVANCE DOUBLE HIGH TIBIAL INSERT

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSH·March 28, 2008

    INDUCTIGRAFT

    FDA Adverse Event
    Injury ·BAXTER APATECH LTD·Product code MQV·January 16, 2014

    INDUCTIGRAFT

    FDA Adverse Event
    Injury ·BAXTER APATECH LTD·Product code MQV·June 10, 2013

    INDUCTIGRAFT

    FDA Adverse Event
    Injury ·BAXTER APATECH LTD·Product code MQV·February 16, 2012

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014