BEUDAMED
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    NAVIGABLE BRAIN BIOPSY CANNULA SET

    FDA 510(k)
    FDA Class 2 ·Neurology

    ForPro

    FDA UDI
    Tng Worldwide, Inc.·00672047204781·Black Nitrile Glove Size X-Large 1000ct

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925016989·RICHARDS RIBBON LOOP 4.5 MM LENGTH PLATINUM

    SSW CARBIDE

    FDA UDI
    Ss White Burs, Inc.·D6901407052·FG SL CARBIDE 700 - 5 PACK

    Foot Osteotomy Wedge System

    FDA UDI
    Tyber Medical, LLC·M6951407050·CerviFuse Lordotic Spacer, 11 x 14 x 5mm

    BONASTENT® Tracheal/Bronchial

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369468565·

    ZYNO Z-800 INFUSION SYSTEM MODEL Z-800

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APNEA RISK EVALUATION SYSTEM (ARES)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AFFINITY OXY NT 511

    FDA Adverse Event
    Malfunction ·MEDTRONIC PERFUSION SYSTEMS·Product code DTZ·October 3, 2014

    SIL-0

    FDA Adverse Event
    Malfunction ·DEPUY SNYTHES POWER TOOLS·Product code GFF·May 31, 2013

    POSEY STAYSAFE BED

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code FNL·June 15, 2011

    ITW Dymon Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt. 16 oz (1 lb), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #52820. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) Renown Lemon Disinfectant Deodorant, Distributed by AmSan, LLC, Deerfield, IL; (2) Concept Lemon Scented Disinfectant Deodorant, Product 5282057750, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA.

    FDA Recall
    Terminated ·ITW Dymon·February 15, 2005

    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

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013