BEUDAMED
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    BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056387·Zirlux Multi Anterior A3.5,98.5X22

    Silverbolt/Mainframe

    FDA UDI
    Choice Spine, LP·10885862163615·

    AOS MODULAR NAIL 12.0mm x 34cm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665003222·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033380581·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K0123000·Recovery Tube, MIS

    VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. REG. # 8010379·Product code KWA·March 26, 2014

    SPIKED WASHER 13.5MM/6.5MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HTN·March 20, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 9, 2011

    DEEP BRAIN STIMULATION LEAD (RIGHT-SIDED)

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·February 12, 2008

    ACCUVUE ADVANCE

    FDA Adverse Event
    Injury ·VISTAKON·Product code LPL·October 19, 2007

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 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

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024