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

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    Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517637581·CoRoent Ant TLIF PEEK, 14x13x30mm 12°

    Cardiovive DM AED Battery

    FDA UDI
    Cardiac Science Corporation·00812394020324·IntelliSense lithium battery for Cardiovive DM ...

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221038203·Unitek(TM) Bicuspid Band General Purpose Wide L...

    NOVA-PULSE

    FDA 510(k)
    FDA Class 2 ·Dental

    STEMPRO MSC SFM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LOGIC FEMORAL PS POR RIGHT SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 10, 2025

    LOGIC CR FEMORAL POR, LEFT, SZ 3.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 11, 2024

    IDENTITY ADX XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC. CRMD·Product code DXY·January 13, 2014

    ENDO ILS, 29MM, CURVED

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 3, 2013

    E. WALKER 6MM RT MED FOSSA

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·June 29, 2011

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 26, 2023

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025