BEUDAMED
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    STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE

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

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756001700·Cervical Collar

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034004495·ISOLA SPINE SYSTEM CLOSED DUAL CONNECTOR 4.75 -...

    LATITUDE EV™

    FDA UDI
    TORNIER, INC.·00846832073979·

    PARSFIX CABLE-SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEPUY ASR XL FEM IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 2, 2013

    LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code KZL·March 21, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIAYLZATOREN GMBH·Product code MSF·April 16, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - 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

    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

    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