BEUDAMED
    13 results · 38ms · Sources: EU EUDAMED, US FDA

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    MARK 5 ROBOTIC PIPETTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant

    FDA 510(k)
    FDA Class 2 ·Radiology

    VITEK 2 STREPTOCOCCUS LEVOFLOXACIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LC4200 PCA PLUS AUST

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 8, 2012

    LC4200 PCA AUST

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·October 20, 2010

    PCA PUMP (AUZ)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 13, 2012

    LC4200 PCA PLUS AUST

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2012

    PCA PUMP (AUZ)

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·June 2, 2010

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 13, 2014

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·January 11, 2013

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·November 18, 2010

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021