BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    INTERLOK / HA COPELAND RESURFACING HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890106350·Zirlux Titanium Esthetic Abutment Posterior com...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756185912·ORTHO EXTREMITY TRAY

    CORINNE MCCORMACK INC.

    FDA UDI
    FGX INTERNATIONAL INC.·00193033185438·

    CORINNE MCCORMACK INC.

    FDA UDI
    FGX INTERNATIONAL INC.·00193033185421·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106150·Trial, 26 x 15mm, 8 Degree, Tapered, Straight

    INSET II

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 24, 2025

    Zyphr

    FDA UDI
    STRYKER CORPORATION·04546540517517·3.5mm Zyphr Round Fluted

    Zyphr

    FDA UDI
    STRYKER CORPORATION·04546540517371·3.5mm Zyphr Round Fluted

    Zyphr

    FDA UDI
    STRYKER CORPORATION·04546540517241·3.5mm Zyphr Round Fluted

    MODIFICATION TO HP M2376A DEVICE LINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IVS TUNNELLER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INSET II

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 28, 2025

    BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Injury ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·February 23, 2023

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAD·March 19, 2013

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·February 24, 2011

    RIATA ST OPTIM PASSIVE-FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·May 7, 2021

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012