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

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    BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690123729·Femoral Posterior Augment Trial Size 3+, 10mm

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690121404·Femoral Augment Posterior, Size 3+, 10mm

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702265620·Elvarex 2/Knee High/Slant-Closed Toe/Dotted 5 c...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702444896·Elvarex Forte 3/Knee High/Open Toe/Dotted Silic...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702330243·Elvarex Forte 3/Thigh High/Slant, Open Toe, E-V...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04059993071173·ELVAREX 3/BERMUDA PANTY/BOTH SIDES-TOP FUNC-WAI...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702466768·Elvarex 3/Knee High/Slant-Closed Toe/Dotted sil...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702538199·ELVAREX 1/KNEE HIGH/SLANT-OPEN TOE/DOTTED 5 CM ...

    WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM

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

    PROPOXYPHENE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MetaSystems Probes

    FDA UDI
    MetaSystems Probes GmbH·04251315818125·XL 7q22/7q36, Deletion Probe

    HATCP STEM POR TIB PLT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·March 5, 2024

    EPOC BGE TEST CARD

    FDA Adverse Event
    Other ·EPOCAL INC.·Product code CHL·November 5, 2009

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 30, 2020

    ENERGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013

    PULSE GEN MODEL 104

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·March 25, 2011

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·May 8, 2008

    Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·July 2, 2014

    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016