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

    UNIVERSAL NEURO 2

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154598922·BURR HOLE COVER PLATE WITH TAB, 30mm

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011253620020·ceraMotion® Lf Body Stains A, 2 g / dental cera...

    Truliant

    FDA UDI
    Exactech, Inc.·10885862556820·TRIAL, TIBIAL INSERT, PSC, SIZE 2

    Aneroid Sphygmomanometer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Enovare Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2025

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·August 11, 2011

    VITALITY EL

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·July 15, 2013

    M2A-38 CUP 52MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·December 27, 2018

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    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