BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    OPTIFLOW II FLOWABLE COMPOSITE, LC

    FDA 510(k)
    FDA Class 2 ·Dental

    INTERACTIVE SBM 3.7MMDX13MML 3.0MM PLAT

    FDA Adverse Event
    Injury ·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·October 29, 2025

    ETWO SKIN TREATMENT SYSTEM

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

    REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET

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

    AMISTEM H HA COATED STD STEM SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

    LAMITRODE 8 LEAD, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 14, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 24, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 30, 2014

    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