BEUDAMED
    9 results · 18ms · 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.

    TRUVEL TZ-3X X-RAY DIGITIZING SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Patterson

    FDA UDI
    PATTERSON DENTAL SUPPLY, INC.·D6620708909701·POINT, PAPER, ENDODONTIC

    FLOCONTROL , MODEL 1028

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROSTEP™ TBI™ (Tailors Bunion Implant) System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED EL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·October 29, 2010

    DURATA STS OPTIM ACTIVE FIXATION, F4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NVY·January 13, 2014

    SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·November 14, 2012

    PAEDIATRIC CANNULA, VENOUS

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWF·June 7, 2023

    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