BEUDAMED
    23 results · 23ms · Sources: EU EUDAMED, US FDA

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    Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NA

    FDA UDI
    KEY SURGICAL, INC.·00849771048237·K-Wire and Steinmann Pin Dispensers, 5/64-inch...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694040815·PrimaLIF LLIF 17mm x 26mm Lordotic Trial

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756029858·Cotton Balls

    Spex

    FDA UDI
    SPEX LIMITED·09420051701298·Spex Paediatric 12" wide w/c Padded calf strap

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·December 6, 2023

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·December 6, 2023

    IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)

    FDA 510(k)
    FDA Class 2 ·Immunology

    ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·December 6, 2023

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 14, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 30, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·October 23, 2018

    ENDEAVOR RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·October 23, 2018

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·October 23, 2018

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·October 23, 2018

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·October 23, 2018

    ENDEAVOR RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·October 23, 2018

    3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.

    FDA Enforcement
    Class II ·Ongoing·Arthrex, Inc.·November 21, 2018