BEUDAMED
    11 results · 27ms · 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.

    RAICHEM SPIA C3 REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277131225·Bedrail Alignment Tool Pair

    GLUCOSE (HEXOKINASE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INTELLIVUE INFO CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 1, 2024

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·January 11, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·December 1, 2010

    ACCU-CHEK ® AVIVA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 3, 2014

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    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