BEUDAMED
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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699595·GENUMEDI PSS BLUE, SIZE VII

    RESTORIS Multicompartmental Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699526·GENUMEDI PSS BLUE, SIZE O

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699533·GENUMEDI PSS BLUE, SIZE I

    OLSEN-LAHEY FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896076600·OLSEN-LAHEY FORCEPS RIGHT ANGLED LONGITUDINAL C...

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100011·BARRAQUER WIRE SPECULUM LARGE WITH TABS

    ECHO PRESS-FIT HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304467828·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100103·BARRAQUER SPECULUM SOLID LARGE

    Gruve Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837065133·Fixation Pin

    Echo® Press-Fit Hip System

    FDA UDI
    Biomet Orthopedics, LLC·00887868260971·

    GELSCAN, MODEL 1206

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AIRIS ELITE RAPID BODY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCU-CHEK COMFORT CURVE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·July 22, 2006

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2025

    LIGASURE HS XTD DISP ELEC/CORD

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·May 30, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·August 21, 2008

    ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    BD ACCURI¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·April 12, 2022

    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