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

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    FDA 510(k)
    FDA Class 2 ·Radiology

    CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LIFERAY WL CASSETTE, LIFERAY KW CASSETTE

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

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

    ATTUNE PS FB INSRT SZ 3 12MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code JWH·July 9, 2013

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·December 19, 2022

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 9, 2022

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·January 2, 2025

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 30, 2022

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·July 17, 2024

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2024

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·May 26, 2022

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code PKL·June 9, 2022

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·April 4, 2022

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·September 7, 2023

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·July 17, 2024

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·March 6, 2024