BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    CAAS MR Solutions

    FDA 510(k)
    FDA Class 2 ·Radiology

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1818250·18mm H x 18mm W x 25mm L x 0 degrees XLIF

    SSW CARBIDE GREAT WHITE ULTRA

    FDA UDI
    Ss White Burs, Inc.·D6901818252·GREAT WHITE ULTRA CARBIDE GW856-016S - PACK 5

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L181825120·18mm H x 18mm W x 25mm L XLIF Trial 12 degree L...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X181825120·18mm H x 18mm W x 25mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X18182580·18mm H x 18mm W x 25mm L x 8 degrees XLIF

    Origin 125º Short Neck Hip Stem

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215024109·

    CRYOBALLOON ABLATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    311NNM NARROWAND UV PHTOTHERAPY LIGHT LAMP

    FDA Adverse Event
    Injury ·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD.·Product code FTC·December 22, 2022

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 28, 2025

    GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code FTM·October 17, 2014

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 6, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 8, 2025

    TRI-STAPLE 2.0

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 13, 2024

    LIBRE 2 SENSOR FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·February 9, 2024

    REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 27, 2022

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·March 9, 2021

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026