BEUDAMED
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    ULTRASOUND AI INC.

    FDA registration
    ULTRASOUND AI INC.·1 product·🇺🇸 United States

    AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER

    FDA 510(k)
    FDA Class 2 ·Radiology

    FIELDER 18

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code OCY·June 24, 2024

    EXO IRIS

    FDA Adverse Event
    Other ·EXO IMAGING·Product code IYN·November 8, 2024

    HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 16, 2021

    POLARX FIT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OAE·January 29, 2025

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·August 21, 2025

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    FDA Adverse Event
    Injury ·CORCYM CANADA CORP.·Product code LWR·July 21, 2023

    Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)

    FDA Enforcement
    Class II ·Terminated·Caption Health·July 28, 2021

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code ODG·December 4, 2020

    GROSHONG NXT CV 4F SL BASIC TRAY W/SAFETY INTRODUCER

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (BASD) -3006260740·Product code LJS·June 3, 2021

    Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)

    FDA Recall
    Terminated ·Caption Health·Product code QIH·May 19, 2021

    LAMINAR

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·June 29, 2022

    ELLIPS FX PHACO HANDPIECE

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code HQC·June 29, 2022

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·November 9, 2021

    CENTURION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER·Product code HQC·August 8, 2018

    COVIDIEN PARIETEX HYDROPHILIC ANATOMICAL MESH 15CM X 10CM POLYESTER

    FDA Adverse Event
    Injury ·CARDINAL HEALTH 200, LLC/COVIDIEN·Product code FTL·April 8, 2026