BEUDAMED
    20 results · 31ms · Sources: EU EUDAMED, US FDA

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    JO Agapé Personal Lubricant

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

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704292367·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704912251·

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771048739·K-Wires, Double trocar, .028-inch (0.7mm) diame...

    3M™ Unitek™

    FDA UDI
    3m do Brasil Ltda.·00652221005403·Unitek(TM) Miniature Twin Bracket Roth U/L 5X5 ...

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659483910·K-Wire w. double end trocarpoint _x000D_...

    K-Wire w. double end trocarpoint 0.70mm/152mm, 6 pcs./unit

    FDA UDI
    mahe medical gmbh·EMAHKM710210·K-Wire w. double end trocarpoint 0.70mm...

    INOMAX DS (DELIVERY SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CUBESCAN / BIOCON-700

    FDA 510(k)
    FDA Class 2 ·Radiology

    ISA CO2

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022

    RELION PRIME BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Malfunction ·ARKRAY, INC.·Product code NBW·October 14, 2014

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·June 14, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 30, 2011

    MONOSYN QUICK

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

    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

    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

    EVEREST ® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·STRYKER-SPINE·Product code LXH·September 9, 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