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

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    CO2 Mainstream Sensor

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221118000·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221118150·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221118070·

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205004048·Luna Opal MB Mini .022 LR4 (-12°T +2°A)

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690130024·Retaining Bolt, PS or PS-C Insert, Revision Tib...

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123202553·Webster Needle Holder, TC, Smo

    GOMCO

    FDA UDI
    Allied Medical, LLC·00026072001776·BREAST PUMP, PORTABLE, 1/15HP

    ZAVATION ROD CONNECTOR

    FDA UDI
    Zavation LLC·00197157016760·ROD CONNECTOR, PARALLEL SIDE LOADING 18mm offse...

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167310221118110·

    FORA COMFORTSCAN EAR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570

    FDA 510(k)
    FDA Class 2 ·Neurology

    Widex

    FDA UDI
    Widex A/S·05706069809992·Widex EVOKE E-FS (Tech Black ) 220, Telecoil, R...

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 24, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·November 3, 2014

    UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 11, 2013

    Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·April 12, 2023

    Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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