BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VIBERECT PENILE VIBRATORY STIMULATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RESMED HOSPITAL NASAL MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 31, 2013

    OVATION 3

    FDA Adverse Event
    Malfunction ·GE YOKOGAWA MEDICAL SYSTEMS·Product code LNH·August 28, 2008

    UNIVERSAL DRIVER SHAFT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·June 16, 2011

    Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·May 16, 2018

    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