BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    WOUNDCLOT HEMOSTATIC GAUZE

    FDA 510(k)
    FDA Unclassified ·Unknown

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257129470·20-30 MV FOR MEN CLSC EW STD BLACK III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257128091·20-30 MV FOR MEN SEL EW CLF STD BLK III

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197055604·Backhaus Towel Forceps 110mm,...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197055635·Backhaus Towel Forceps 150mm, 6"

    NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236

    FDA 510(k)
    FDA Class 2 ·Dental

    READY VIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2025

    TOTAL ASR ACET IMP SIZE 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·May 31, 2013

    LOCKING SCREW AXSOS 4.0MM / L40MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code HWC·June 16, 2011

    CIDEX PLUS 28 DAY SOLUTION

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MED·August 28, 2008

    GALAFLEX

    FDA Adverse Event
    Injury ·TEPHA, INC·Product code OOD·February 28, 2020

    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