BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SR PIP

    FDA UDI
    Stryker GmbH·00886385019833·SIZE 5: PIP DISTAL TRIAL

    GE ECHOPAC MODEL BT10

    FDA 510(k)
    FDA Class 2 ·Radiology

    CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. HOMECARE PRODUCT, INC·Product code INI·June 14, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 14, 2014

    EXTRACTOR XL TRIPLE LUMEN RETRIEVAL BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code GCA·September 17, 2008

    ACHIEVE MAPPING CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRF·April 23, 2018

    EVEREST ® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·STRYKER-SPINE·Product code LXH·September 9, 2019

    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 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