BEUDAMED
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    JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040133163·Zirlux TR C1 98x18mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450282779·

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033428450·

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967187266·Battalion, LLIF Trial, 10°, 26 mm Wide, 17 mm X...

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033428443·

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033428436·

    SPIFE IFE CALIBRATOR AND CONTROL KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    PERIFORM PERINEOMETRIC PROBE, MODEL 8300

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

    GENTLECATH INTERMITTENT URINARY CATHETER 14CH

    FDA Adverse Event
    Other ·COVATEC·Product code KOD·March 15, 2013

    UNKNOWN DEPUY 28X56MM 10D INSERT

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

    CONSERVE TOTAL FEMORAL HEAD W/BFH

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·March 10, 2008

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q 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.·October 18, 2017

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020