BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material

    FDA 510(k)
    FDA Class 2 ·Immunology

    Trial Liners (Neutral and 10 degree hooded)

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215038571·

    TREVAIR CHAIR ADULT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MODUS IMF SCREWS 2.0

    FDA 510(k)
    FDA Class 2 ·Dental

    BD WHITACRE SPINAL NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code BSP·March 27, 2007

    IDENTITY XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.,CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 7, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    PEDICLE SCREW LATERAL CONNECTOR L150

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2023

    OTIS SCREW

    FDA Adverse Event
    Injury ·S.B.M. SAS·Product code HWC·April 11, 2019

    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