BEUDAMED
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    Juliet® Ti LL Lumbar Interbody Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Symmetry Jansen

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482060988·Symmetry® Retractor, Jansen Scalp, 4 x 4 Prong,...

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517084788·

    T:SLIM G4 SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code OYC·December 9, 2016

    VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM

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

    GLUCOSTABILIZER INSULIN DOSING CALCULATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962114728·JANSEN SCALP RETRACTOR, 4 3/8", 4X4 PRONG, BLUNT

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 10, 2014

    POSEY KEEPSAFE DELUXE ALARM

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·September 2, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 22, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020