BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    ANODYNE ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GenePOC™ CDiff

    FDA UDI
    GenePoc Inc·00628055344025·The GenePOC™ CDiff assay performed on the revog...

    K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)

    FDA 510(k)
    FDA Class 2 ·Neurology

    STEM COLLARED HA COATED STD STEM SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2018

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·February 20, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code KNQ·September 7, 2012

    CRE? WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 18, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·January 7, 2013

    FLEXICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·May 29, 2013

    IAB : 8 FR - 40 CC FOS

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·September 29, 2014

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 17, 2011

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·March 13, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·August 10, 2012

    Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·November 25, 2020

    CRE? WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 6, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KNQ·December 5, 2012

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KNQ·July 2, 2012

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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