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

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    Alta Multipurpose Device

    FDA 510(k)
    FDA Class 2 ·Radiology

    2.4MM VA-LCP INTERCARPAL FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·October 24, 2015

    VSP SYSTEM

    FDA Adverse Event
    Injury ·3D SYSTEMS·Product code DZJ·December 18, 2020

    VA LOCKSCR Ø2.4 SELF-TAP L12 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 18, 2013

    BD ULTRA-FINE¿ INSULIN SYRINGES

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 21, 2018

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 14, 2008

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·August 5, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 27, 2013

    VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·April 27, 2022

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·July 30, 2015

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HWC·December 30, 2014

    UNK - SCREWS: 2.7 MM VA LOCKING

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·March 1, 2024

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·July 22, 2016

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 12, 2016

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·October 24, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·October 1, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·October 24, 2015

    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