BEUDAMED
    19 results · 27ms · Sources: EU EUDAMED, US FDA

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    Elecsys Progesterone III CalSet

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014447·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 26

    Trial Liners (20 degree hooded)

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215038793·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161121525260·Trial Liner 20° 36/60-70 (E)

    BLO2X OXYGEN BLOCKER

    FDA 510(k)
    FDA Class 2 ·Dental

    NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 7, 2013

    VENTURI PHACO PACK

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQC·June 22, 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

    SCREWDRIVER BIT T15, AO FITTING

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HWC·October 6, 2017

    SCREWDRIVER BIT T15, AO FITTING

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HWC·October 6, 2017

    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

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 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