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

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    syngo.CT LVO Detection

    FDA 510(k)
    FDA Class 2 ·Radiology

    BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SafeAir Smoke Pencil

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

    CLINITEK STATUS+

    FDA Adverse Event
    SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·May 16, 2016

    IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 8MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·June 1, 2022

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025

    OPTI-FREE REPLENISH

    FDA Adverse Event
    Injury ·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPN·November 21, 2008

    THORATEC PVAD

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·September 11, 2011

    ASCENDRA INTRODUCER SHEATH SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·July 23, 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

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020