BEUDAMED
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    MAGNETOM ALLEGRA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002179·artVeneer life lower posteriors, XS, BL2

    NUZONE NITRILE SURGICAL GLOVES POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SUPER NOVA, ACUBEAM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MPACT OFFSET 4MM PE HC LINER 32/C

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 4, 2021

    MIO¿ ADVANCE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 27, 2024

    MIO¿ ADVANCE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 27, 2024

    MIO¿ ADVANCE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 27, 2024

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·December 10, 2024

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·November 29, 2024

    LINOX TD 65/16

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·March 13, 2013

    QUANTA SYSTEM

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·August 6, 2014

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·February 18, 2011

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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