BEUDAMED
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    GUARDIAN-SG Inflatable Bone Expander System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169631816·DISTRACTOR 2143006 6MM COBB DISTRACTOR

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756614573·Knee Immobilizer

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694009102·6 Hole Straight Compression Plate

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506084010·SILICONE TUBING FOR ELLIK 1FT

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011644·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 6

    I-FUSE HAMMER TOE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GORE HELEX SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MLV·May 23, 2013

    PLUM XLD 110V L.A.

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·September 12, 2014

    DORC

    FDA Adverse Event
    Malfunction ·DORC INT'L BV·Product code HQF·June 20, 2011

    ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M

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

    Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, disposable, single use accessory to the TEM (Transanal Endoscopic Microsurgery) System used for insufflation of the rectal cavity; Manufacturer: Richard Wolf GmbH, Postfoch 1164, D-75343 Knittlingen, Deutschland; Product Number 4170.801

    FDA Recall
    Terminated ·Richard Wolf Medical Instruments Corp.·Product code HIF·July 7, 2006

    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