BEUDAMED
    12 results · 21ms · 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 ×

    NET BRAND Osteosynthesis Nailing System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VK Couture

    FDA UDI
    Diversified Products, Inc.·00842894182949·

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668103364·CASTROVIEJO SYNECHIAE SPATULA

    IdentiTi

    FDA UDI
    ALPHATEC SPINE, INC.·00190376382982·IdentiTi ALIF SA, Inserter, Anterolateral

    NEXUS

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·July 3, 2024

    ART POSTERIOR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Cool-tip RF Ablation System E Series

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

    SJM MECHANICAL HEART VALVE (UNKNOWN)

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, INC. (CS)·Product code LWQ·November 6, 2014

    CORE UNIVERSAL DRIVER

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·July 22, 2011

    UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 18, 2013

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025