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

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    ICRCO CLARITY VIEWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    DUOFERTILITY

    FDA 510(k)
    FDA Unclassified ·Unknown

    A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PINNACLE MTL INS NEUT36IDX58OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 25, 2013

    PINN SECTOR HA ACET CUP 58MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·April 25, 2013

    ARTICULEZE M HEAD 36MM -2

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code JDI·April 25, 2013

    CORAIL2 STD SIZE 12

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS 3003895575·Product code KWA·April 25, 2013

    RSP SHOULDER

    FDA Adverse Event
    Injury ·ENCORE MEDICAL, L.P.·Product code KWS·October 1, 2014

    PROTECTA CRT-D

    FDA Adverse Event
    Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·May 29, 2013

    HUMAPEN MEMOIR

    FDA Adverse Event
    Injury ·ELI LILLY AND COMPANY·Product code NSC·June 17, 2011

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·April 6, 2023

    PINNACLE MTL INS NEUT36IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 6, 2013

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 6, 2013

    VITEK MASS SPECTROMETER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code PEX·October 12, 2017

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024