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

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    AEU-14CF EXPENDITION

    FDA 510(k)
    FDA Class 1 ·Dental

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034004815·ISOLA SPINE SYSTEM SPEED WRENCH 7.94mm

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110610·LOCATOR R-Tx Abutment for Wide Platform (WP) In...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481121104·LOCATOR F-Tx Abutment For Wide Platform (WP) In...

    OptiLIF Endo, Direct Visualization System

    FDA UDI
    SPINEOLOGY INC.·M7401050201·30° Ring Curette

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481128783·LOCATOR R-Tx Abutment, Wide Platform (WP) Tri-c...

    P102, S102, 2 FT, NO DP, CURBELL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828164153·P102, S102, 2 FT, NO DP, CURBELL

    BAYER ADVIA IMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HARDYDISK, STREPTOMYCIN 10MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

    FDA Adverse Event
    Injury ·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019

    PUMP 371 14F LT CMR SET

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·February 6, 2026

    SUREFLEX LITHOTRIPSY FIBER

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 5, 2013

    ENTERRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·April 1, 2011

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·May 23, 2008

    PILLING GOULIAN GUARD .004 GAUGE

    FDA Adverse Event
    Injury ·TELEFLEX MEDICAL·Product code EMF·December 1, 2025

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015