BEUDAMED
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    MODEL 1300GE-64: PEDIATRIC POSITIONER

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496030317·VENERE 70, SIZE XXL, BRONZE, GRADUATED COMPRESS...

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RENEW LS-1

    FDA 510(k)
    FDA Class 2 ·Dental

    ZEPHIR® ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·April 24, 2014

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 18, 2011

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·January 3, 2017

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·September 20, 2013

    HEARTMATE II LVAD

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·March 28, 2013

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 7, 2011

    INFUSOR PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·April 16, 2008

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·October 12, 2011

    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