BEUDAMED
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    DIAGNOSTIC CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122186·KWire .035x6" (0.9x150mm)

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122179·KWire .035x6" (0.9x150mm) Threaded

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450282816·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450272251·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450270110·

    BD ULTRA FINE¿ PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·December 10, 2021

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0192500·Dissector, Tissue, MIS

    VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)

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

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·August 21, 2024

    AS3000 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code BSZ·April 30, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 5, 2014

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 17, 2011

    4.0MM HEXAGONAL SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code HXX·September 22, 2016

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    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

    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