BEUDAMED
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    Single Use Aspiration Needle

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Cascade Elite

    FDA UDI
    CADWELL INDUSTRIES, INC.·00840067100271·Cascade Elite

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306804335·Sheen Retractor, 6.5 mm, 15 cm / 6 in

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319756898·Sinus Giraffe Forceps, double action cupped for...

    LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PROGASTRO CD ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 10, 2013

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·August 4, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 21, 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