BEUDAMED
    16 results · 31ms · Sources: EU EUDAMED, US FDA

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    INTRAMEDULLARY NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327300031·PEEK CUSTOMIZED-PLUS-XL

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867317925·Termite Forceps

    Tecomet

    FDA UDI
    TECOMET INC.·00841435124752·Forceps, Termite

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024559011·

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024559004·

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024559028·

    BePOD Cannulated Arthrodesis Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    UNK

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·March 3, 2023

    VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·June 12, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR...·Product code CBK·December 10, 2012

    HARMONIC SYNERGY* DISSECTING HOOK

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 15, 2010

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024