BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL

    FDA 510(k)
    FDA Class 2 ·Hematology

    PG&E Wilderness Tactical - Trauma Bag

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588233178·PG&E Wilderness Tactical - Trauma Bag

    CLEARVIEW HCG DEV(URINE)20T

    FDA Adverse Event
    Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·June 22, 2024

    METHADONE ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CLEARVIEW HCG DEV(URINE)20T

    FDA Adverse Event
    Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·June 6, 2025

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·January 22, 2013

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·November 19, 2010

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014

    ALERE HCG CASSETTE

    FDA Adverse Event
    Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·May 25, 2023

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023