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

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    Ponto bone anchored hearing system

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Trial Liners (Neutral and 10 degree hooded)

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215038632·

    ENDOSKELETON TO

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DOPPLER GUIDED PROCTOSCOPE, MODEL 500H

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 22, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    ENDURON 10D 54OD X 26ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code HRY·September 18, 2017

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026

    KYPHON BONE CEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025

    1030489-2019-01423

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 7, 2011

    OSTEOCOOL RF ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 2025

    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