BEUDAMED
    17 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    BLANKET, WATER-JEL FIRE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ILIF

    FDA UDI
    Nuvasive, Inc.·00887517263360·ILIF Trial, 10mm

    Ceramill® ZI

    FDA UDI
    Amann Girrbach AG·E4947602101·

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110546·QUICK SWITCH IRRIGAT-ASPIRAT HAND PIECE

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00843471178461·Anatomical Molar Bands, Upper Right 1St & 2Nd M...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110553·COAXIAL IRRIGAT-ASPIRAT TIP STR 0.3 PORT

    EnSite Precision Cardiac Mapping System v2.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDIPORT

    FDA 510(k)
    FDA Class 2 ·Radiology

    MD HYBRID GLENOID BASE 4MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·May 13, 2019

    VERSA-DIAL/COMP TI STD TAPER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·May 13, 2019

    VERSA-DIAL 50X21X57 HUM HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·May 13, 2019

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

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

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HLTHCARE CORPORATION·Product code FRN·September 20, 2012

    SPACEMAKER PREPERITONEAL DIST BALLOON

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

    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

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 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