BEUDAMED
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    SYNELISA CARDIOLIPIN ANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Immunology

    Bosworth Trusoft

    FDA UDI
    Harry J Bosworth Company·H66809212501·PEMA Denture Reline P&L Standard Kit

    i-ED COIL

    FDA UDI
    KANEKA CORPORATION·04540778177222·The i-ED COIL is used for vascular embolization...

    Bioseal Inc.

    FDA UDI
    BIOSEAL·00630094192123·00630094192123

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111017·SILICONE MAT FOR INSTRUMENT CADDY

    MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)

    FDA 510(k)
    FDA Class 2 ·Dental

    OP SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021

    TAPERLOC POROUS LATERAL FEMORAL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·January 3, 2020

    M2A-MAGNUM TAPER INSERT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·January 3, 2020

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 17, 2015

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·December 13, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 6, 2014

    M2A-MAGNUM MODULAR HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·January 3, 2020

    AUTOSOFT XC

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·July 25, 2024

    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