BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    RENASYS Touch; RENASYS Y-Connector

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

    SureCore Automatic Disposable Biopsy Needle

    FDA UDI
    Canyon Medical Inc.·06954414659078·Automatic Disposable Biopsy Needle

    SureCore Automatic Disposable Biopsy Needle

    FDA UDI
    Canyon Medical Inc.·06954414659276·Automatic Disposable Biopsy Needle

    SureCore Automatic Disposable Biopsy Needle

    FDA UDI
    Canyon Medical Inc.·06954414661972·Automatic Disposable Biopsy Needle

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704512953·

    mambo™ modular cervical plate system

    FDA UDI
    Ulrich GmbH & Co. KG·04052536008056·mambo plate XS violet, 4-hole, length 22 mm

    COULTER 6C CELL CONTROL, MODELS 628027 & A59925

    FDA 510(k)
    FDA Class 2 ·Hematology

    NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 28, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 25, 2024

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 21, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·July 28, 2011

    LIFEVEST WCD 400 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·August 4, 2014

    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    FDA Enforcement
    Class III ·Terminated·Diagnostica Stago, Inc.·September 24, 2014

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 8, 2025

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·November 26, 2025

    REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 27, 2022

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·March 9, 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