BEUDAMED
    196 results · 20ms · 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.
    Filters Status: Open, Classified ×

    Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

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

    Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

    FDA Recall
    Open, Classified ·Wiener Laboratories Street Riobamba Argentina·Product code MIU·November 10, 2017

    Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.

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

    Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.

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

    Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FJL·November 11, 2025

    Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FJL·November 11, 2025

    Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FJL·November 11, 2025

    Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code HIH·November 11, 2025

    Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FJL·November 11, 2025

    Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code GCP·November 11, 2025

    Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FJL·November 11, 2025

    Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FJL·November 11, 2025

    Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·January 3, 2024

    Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·January 3, 2024

    EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.

    FDA Recall
    Open, Classified ·Epitope Diagnostics, Inc.·Product code QKO·October 1, 2020

    SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DQO·June 18, 2024

    Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code MMI·April 7, 2021

    SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DQO·June 18, 2024

    Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code MMI·April 7, 2021

    Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.

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