BEUDAMED
    11 results · 12ms · Sources: EU EUDAMED, US FDA

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    Encision ES4107 Disposable AEM Cord, Sterile.

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·July 9, 2004

    AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 11, 2004

    CryoValve, Pulmonary Valve & Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·July 15, 2004

    Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·September 15, 2004

    Stockert 70 Radio Frequency Ablation Generator

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·July 16, 2004

    ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics, Irvine, CA; and Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials distributed by Horiba Ltd., Kyoto, Japan

    FDA Recall
    Terminated ·R & D Systems, Inc·Product code JPK·April 15, 2004

    The device is labeled as AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the Operating Room at Hospitals) and is labeled as ''MANUFACTURED FOR ARZCO MEDICAL SYSTEMS, INC. PO BOX 1048, TAMPA, FL 33601 1-800-231-6370 MODEL S/N''

    FDA Recall
    Terminated ·Cardiocommand Inc.·Product code LPA·October 27, 2003

    OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code IZL·March 27, 2007

    OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code IZL·March 27, 2007

    UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging applications at the physician's discretion.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·March 27, 2007

    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