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

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    NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE

    LYSUS INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OSTENE CT, AOC CT, OSTEOTENE, CERETENE

    FDA 510(k)
    FDA Unclassified ·Unknown

    Herbert/Whipple®

    FDA UDI
    Zimmer, Inc.·00889024034006·

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·July 7, 2011

    SPECTRA OPTIA

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code LKN·October 8, 2014

    RE-MANUFACTURED IPUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·September 15, 2008

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·April 27, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·April 11, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 19, 2022

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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