BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CRE DITATATION BALLON

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

    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

    RADIUS-7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·July 2, 2015

    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

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014

    ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM

    FDA Adverse Event
    Injury ·STRYKER SPINE-FRANCE·Product code NKB·June 3, 2013

    SPECTRA OPTIA COLLECT SET

    FDA Adverse Event
    Other ·CARIDIANBCT·Product code LKN·June 21, 2011

    CRE¿ WIREGUIDED

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

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    CRE¿ WIREGUIDED

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

    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

    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