BEUDAMED
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    Caption Health, Inc.

    Manufacturer
    🇺🇸 United States·2 Basic UDI-DIs·2 Devices

    Caption Guidance

    Device
    EU MDR · Eu Md Class 2a ·Caption Health, Inc.·On the market·1 country

    ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES

    Device
    EU MDR · Eu Md Class 2a ·Caption Health, Inc.·On the market·27 countries

    Caption AI (Caption Guidance + Caption Interpretation)

    FDA UDI
    CAPTION HEALTH, INC.·00860003586341·

    Caption AI (Caption Guidance + Caption Interpretation)

    FDA UDI
    CAPTION HEALTH, INC.·00860003586310·Caption AI (Caption Guidance + Caption Interpre...

    Caption Guidance

    FDA UDI
    CAPTION HEALTH, INC.·00860003586334·The Caption Guidance software is intended to as...

    Caption AI (Caption Guidance + Caption Interpretation)

    FDA UDI
    CAPTION HEALTH, INC.·00860003586303·The Caption Guidance software is indicated for ...

    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

    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

    Caption AI on vScan

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Caption Health, Inc.·1 device

    Caption Guidance

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Caption Health, Inc.·1 device

    24 FR RESECTOSCOPE SHEATH

    FDA Adverse Event
    Malfunction ·R. WOLF, GMBH·Product code FDC·July 18, 1994

    MENISCUS GRASPING FORCEP BY O'CONNOR

    FDA Adverse Event
    Malfunction ·R. WOLF, GMBH·Product code HTD·October 13, 1994

    ARTHROSCOPIC MENISCUS GRASPING FORCEPS

    FDA Adverse Event
    Malfunction ·R. WOLF, GMBH·Product code GEN·July 18, 1994

    KLEPPINGER FORCEPS

    FDA Adverse Event
    Malfunction ·R. WOLF GMBH·Product code HTD·July 18, 1994

    DOUBLE SPOON FORCEP FOR SINUSCOPY

    FDA Adverse Event
    Malfunction ·R. WOLF, GMBH·Product code KAE·July 18, 1994

    GRASPER AND AMPULLA DILATOR

    FDA Adverse Event
    Malfunction ·R. WOLF, GMBH·July 18, 1994

    GRASPER AND AMPULLAAR DILATOR

    FDA Adverse Event
    Malfunction ·R. WOLF, GMBH·Product code KOE·July 18, 1994

    EFFICIA DFM100

    FDA Adverse Event
    Injury ·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.·Product code MKJ·November 28, 2023

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code MJP·July 26, 2024