BEUDAMED
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    PEREGRINE WIDE ANGLE LIGHT PIPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150690·K-WIRE - SINGLE TROCAR 0.9mm DIA x 75mm

    RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RIVA LUTING

    FDA 510(k)
    FDA Class 2 ·Dental

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 5, 2022

    TEGRESS URETHRAL IMPLANT

    FDA Adverse Event
    Injury ·BARD PUERTO RICO·Product code FBK·June 18, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 3, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 9, 2010

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020

    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