BEUDAMED
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    SIEMENS INFINITY SC 6002XL MODIFICATIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    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

    Latitude™ EV

    FDA UDI
    TORNIER, INC.·00846832002764·Humeral Stem - Coated

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6911030313·CURETTE NOVAK BIOPSY 3MM

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481477023·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103130·Shaver, Closed, 13mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024083·Paddle Shaver, 13mm

    TEARAWAY INTRODUCER SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FILAC FAS TEMP ELECTRONIC THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 29, 2018

    PICC SET

    FDA Adverse Event
    Injury ·ARROW INTL., INC.·Product code LJS·March 28, 2013

    SELOX ST 53

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·March 21, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 16, 2008

    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