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

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    Single Use Hemoclip

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

    Bernafon

    FDA UDI
    Bernafon AG·05711584114353·AN3, BTE SP 2.4G NFM ANBR ALTENA 3 GPL

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704514513·

    NEEDLE 18X1-1/2 BLUNT FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code GAA·March 24, 2025

    REPROCESSED ELECTROSURGICAL ELECTRODES

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

    TATTOOSTAR EFFECT Y

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

    NEEDLE 18X1-1/2 BLUNT FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code GAA·January 24, 2025

    NEEDLE 18X1-1/2 BLUNT FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code GAA·December 13, 2024

    NEEDLE 18X1-1/2 BLUNT FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code GAA·January 22, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2024

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·October 20, 2008

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, B.V.·Product code MGB·August 10, 2011

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    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