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

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    Exactech® Truliant™ Line Extensions

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 15, 2024

    TRU CC FEMORAL SIZE 1 LEFT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 15, 2025

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517292742·CoRoent® XLFW, 10x22x45mm Lordotic

    CENTRO FAMILY OF MANUAL WHEELCHAIRS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HUMAN ALBUMIN CSF KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 14, 2014

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 14, 2013

    5.0MM CANNULATED LOCKING SREW

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·July 8, 2011

    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

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026