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

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    Ceramax Skin Barrier Cream

    FDA 510(k)
    FDA Unclassified ·Unknown

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741520550·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674152055060·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704283471·KMEDIC SKIN HOOK 4 3/4" SHARP 2 MILLIMETER

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036054229·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111250910·OP SCISS 5 1/2" CVD BL/BL

    SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AMSCO CHIMERON MEDIUM STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Herbert/Whipple®

    FDA UDI
    Zimmer, Inc.·00889024033979·

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 26, 2024

    KYPHON BONE CEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019

    1030489-2019-01423

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014

    COLLEAGUE PRE P1.7

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

    SPRINT QUATTRO

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 7, 2013

    OSTEOCOOL RF ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020

    BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.

    FDA Enforcement
    Class II ·Ongoing·Becton, Dickinson and Company, BD Biosciences·November 9, 2022

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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