BEUDAMED
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    BenestaTM Tissue Removal Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Futar

    FDA UDI
    Kettenbach GmbH & Co. KG·E21711928111·Futar Clear Fast Normal pack

    AOS ORION IR-192 SOURCE CABLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·August 10, 2020

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 7, 2016

    POUNCE VENOUS THROMBECTOMY SYSTEM

    FDA Adverse Event
    Injury ·SURMODICS INC·Product code QEW·May 16, 2024

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 27, 2013

    OSVII CONNECTOR WITH ANTECHAMBER

    FDA Adverse Event
    Malfunction ·INTEGRA, BIOT·Product code JXG·July 20, 2011

    Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    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