BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KANEDA SR

    FDA UDI
    Medos International Sàrl·10705034004693·KANEDA SR ANTERIOR SYSTEM CLOSED SCREW TIP 4.75...

    HairCheck-DT (THC)

    FDA UDI
    Quest Diagnostics·00868586000247·HairCheck-DT (THC) is an ELISA test kit used fo...

    Gladstone ALIF Trial Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215045272·

    SUPPORT SLEEVE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HARDYDISK, CIPROFLOXACIN, 5MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

    4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 18MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KWQ·April 8, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·April 5, 2011

    F/G ATLANTIS SR PRO2

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code DQO·May 7, 2008

    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