BEUDAMED
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    MTP UROPUMP DISPOSABLE TUBING SET

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

    AETOS Shoulder System

    FDA UDI
    Smith & Nephew, Inc.·00885556813379·ANATOMIC INSTRUMENT TRAY ...

    ArtiSential Bipolar Fenestrated Forceps

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

    C-QUR V -PATCH MESH

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

    SUPRAMID BLACK 4/0 (1.5) 45CM DS19

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAR·September 12, 2019

    ROTALINK¿ PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MCX·March 6, 2013

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·August 8, 2014

    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