BEUDAMED
    18 results · 32ms · Sources: EU EUDAMED, US FDA

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    Integra DigiFuse Cannulated Intramedullary Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BASIX COMPAK INFLATION SYRINGE KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·March 14, 2011

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014454·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 27

    OrthoMedFlex, LLC

    FDA UDI
    ORTHOMEDFLEX LLC·M7161121525270·Trial Liner, 40/56-58D (20 degree Hooded)

    Trial Liners (20 degree hooded)

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215038809·

    IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER

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

    NEUROPROBES

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011

    AXSYM RUBELLA IGG ANTIBODY

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code LFX·September 10, 2008

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·April 25, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·January 4, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·February 18, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·July 26, 2019

    TR BAND

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

    TR BAND

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 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