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

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    ANALYZER, GLUCOSE/UREA/CREATININE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Ceramill® ZI

    FDA UDI
    Amann Girrbach AG·E4947602111·

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00843471178485·Anatomical Molar Bands, Upper Right 1St & 2Nd M...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110560·COAXIAL IRRIGAT-ASPIRAT TIP STR 0.4 PORT

    Performa®

    FDA UDI
    Merit Medical Systems, Inc.·00884450004616·

    Wet Original Personal Lubricant

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

    WUZHOU SYRINGE, WITH/WITHOUT NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code FKX·April 18, 2014

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·September 20, 2012

    INSUFFLATION/ACCESS NEEDLE 14 GAUGE

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GCJ·July 12, 2010

    Various eye packs, cataract packs

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·September 14, 2022

    Various Laparoscopy Packs

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·September 14, 2022

    Various convenience packs

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·September 14, 2022

    Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics, Inc.·March 12, 2025

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021