BEUDAMED
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    SOFIA(R) RSV FIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ArgenZ HT+ 98x25 ML C2B

    FDA UDI
    ARGEN CORPORATION, THE·D818130398·Dental porcelain/ceramic restoration kit

    EMERGE?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026

    CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COMP LK SCR 3.5HEX 4.75X25 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·September 19, 2022

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTO·May 24, 2013

    TRIFECTA¿ VALVE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, COSTA RICA LTDA·Product code LWR·September 30, 2014

    KAPPA 900 DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021