BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    MDx-Chex for BCID2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Bernafon

    FDA UDI
    Bernafon AG·05711584115411·CO3 MNR, 2.4G NFM MAC CAPTO 3 GPL

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776162832·Saye/Reddick Knot Pusher, opened, 5mm x 38cm

    CIC-C1Q EIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    ENDOCHOICE WATER BOTTLE CAP SYSTEM

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

    8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 315MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code JDS·March 19, 2015

    BIOINTRAFIX SHEATH

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·October 24, 2008

    EON MINI 16-CHANNEL IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 11, 2011

    RENAISSANCE 29 P-WASHOBS10/04

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 9, 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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023