BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    F&P Optiflow Oxygen Kit (AA451J)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMPRINT ABLATION SYSTEM

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

    IMP,TSV,MCOL MG,4.1MM,10M

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 2, 2024

    IMP,TSV,MCOL MG,3.7MM,10M

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 26, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 6, 2014

    REMB MICRO DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·July 18, 2013

    LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·November 18, 2015

    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