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

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    SilverSeal

    FDA 510(k)
    FDA Unclassified ·Unknown

    3M™ Unitek™

    FDA UDI
    3m do Brasil Ltda.·00652221005427·Unitek(TM) Miniature Twin Bracket Roth U/L 5X5 ...

    COAGUCHEK XS PLUS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    DC-7 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 14, 2013

    TERUMO CDI 540 CALIBRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DRY·July 1, 2011

    MONOSYN QUICK

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·May 20, 2022

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code DXY·April 13, 2018

    MONOMEND ST 4/0 18''(45CM) HR17 VPL .RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·May 5, 2026

    MONOMEND ST5/0 18"(45CM)DSMP11(M)VPL.RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·January 2, 2023

    TRU CC FEMORAL SIZE 1 LEFT

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

    MONOMEND ST5/0 18"(45CM)DSMP11(M)VPL.RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·January 2, 2023

    MONOMEND ST 5/0 18''(45)DSMP13(M)VPL.RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 25, 2026

    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