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

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    Medical Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114001·CHANG HYDRO-DISSECT CANNULA 27GA

    DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IMUBIND PLASMA PAI-1 ELISA,MODEL 822

    FDA 510(k)
    FDA Class 2 ·Hematology

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    FDA Enforcement
    Class II ·Terminated·Anodyne Surgical·June 23, 2021

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 14, 2016

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    SELUTE

    FDA Adverse Event
    Injury ·HISTORICAL PUERTO RICO·Product code NVN·July 9, 2013

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    FDA Recall
    Terminated ·Anodyne Surgical·Product code HMX·April 21, 2021

    ALINITY I RUBELLA IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 26, 2025

    ALINITY I RUBELLA IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 7, 2025

    GLENOSPHERE IMPACTOR-EXTRACTOR

    FDA Adverse Event
    Malfunction ·LIMACORPORATE S.P.A.·Product code KWS·September 20, 2022

    ALINITY I RUBELLA IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·February 13, 2026

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023