BEUDAMED
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    Stryker CMF MEDPOR Customized Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707015000·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 8

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828160889·GEN4 Direct Access

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111085437·SKLHN METZ SCISS SMO STR 8"

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383507578·Gutta Percha Points is used to root canal filin...

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE

    UNMIAX LAPAROSCOPIC INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYNFIX-LR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ESON 2 NASAL MASK

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 16, 2025

    LINEAR? ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 9, 2026

    ELLIPSE DR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014

    ATTAIN ABILITY PLUS

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 8, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021