BEUDAMED
    29 results · 24ms · Sources: EU EUDAMED, US FDA

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    Phasix ST Mesh

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

    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

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100868·MCNEILL GLOBAL FIXATION RING LARGE

    MODIFIED VERTIFLEX SPINAL SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARSTASIS ONE LATCHWIRE ACCESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SLEEPSTYLE AUTO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·January 2, 2025

    SLEEPSTYLE AUTO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·February 18, 2025

    SLEEPSTYLE AUTO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·September 12, 2024

    VSP SYSTEM

    FDA Adverse Event
    Injury ·3D SYSTEMS·Product code DZJ·December 18, 2020

    SLEEPSTYLE AUTO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·November 14, 2024

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    FDA Adverse Event
    Malfunction ·BATTLE CREEK EQUIPMENT CO.·Product code IRT·June 5, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 23, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008

    PIVET GUIDE EMBRYO TRANSFER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MQF·September 6, 2024

    PIVET GUIDE EMBRYO TRANSFER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MQF·September 10, 2024

    PIVET GUIDE EMBRYO TRANSFER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MQF·September 6, 2024

    PIVET GUIDE EMBRYO TRANSFER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MQF·August 11, 2023

    SOFT-PASS ECHOTIP EMBRYO TRANSFER CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MQF·October 14, 2020

    PIVET GUIDE EMBRYO TRANSFER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MQF·June 16, 2022

    PIVET GUIDE EMBRYO TRANSFER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MQF·September 27, 2024