BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    Camber Spine Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127029431·Bipolar Head Assembly, Size 38mm

    Cupped Straight

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215164805·

    Endosee System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    A200 KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADD EXTENSTION SET

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·April 27, 2022

    CADD EXT SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·March 2, 2022

    UNKNOWN

    FDA Adverse Event
    Injury ·TOTAL KNEE PROSTHESIS·Product code JWH·September 8, 1993

    CADD EXT SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LHI·July 20, 2022

    ACCESS TOTAL BHCG (5TH IS) ASSAY

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code DHA·November 3, 2014

    LIGASURE IMPACT

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 12, 2011

    ELLIPSE DR, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 3, 2023

    iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

    FDA Enforcement
    Class II ·Ongoing·Theken Companies LLC·October 29, 2025

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 30, 2024

    iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

    FDA Recall
    Open, Classified ·Theken Companies LLC·Product code MEH·September 11, 2025

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023