BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    NEOSS IMPLANT SYSTEM 03.25

    FDA 510(k)
    FDA Class 2 ·Dental

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065661·INTRAORAL ELASTICS 2,5 oz 5/16" blue

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450205815·

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN·Product code BTR·February 26, 2014

    SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LANX SPINOUS PROCESS FUSION PLATE

    FDA Adverse Event
    Injury ·LANX, INC.·Product code KWP·March 17, 2011

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NDN·March 14, 2018

    PROXIMATE PPH PROCEDURE SET

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 2, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 15, 2014

    CAPSURE Z NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 16, 2011

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025