BEUDAMED
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    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

    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

    SAVINA 300

    FDA Adverse Event
    Malfunction ·DRÄGERWERK AG & CO. KGAA·Product code CBK·June 23, 2025

    Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·November 16, 2022

    Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·November 16, 2022

    Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·November 16, 2022

    Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·November 16, 2022