BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Koios DS for Breast

    FDA 510(k)
    FDA Class 2 ·Radiology

    FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM

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

    NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 26, 2013

    GUT SURGICAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAL·July 28, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 16, 2014

    PRESIDIO 18 CERE 9MMX33CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·March 9, 2021

    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