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

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    STONELITH, MODEL V5

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NVJJB

    FDA UDI
    Nuvasive, Inc.·00887517063489·NVJJB Clips, Large Dynamic Stim Sterile

    Invenio

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918181554·TUR Drape_160x217x260cm_Sterile_12ea/cs

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930701110600·Custom Pattie Tray 11"x6" No Lip

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112060·Tap, 6.50mm

    Navigation Unit Cube4D

    FDA UDI
    Fiagon GmbH·04260759930133·Navigation unit, Component of Cube4D Navigation...

    4K Navigation Unit Cube4D

    FDA UDI
    Fiagon GmbH·04260759930157·Navigation unit 4K, Component of Cube4D Navigat...

    AMYSEAT TILT/RECLINE SEATING

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 29, 2025

    RIWOtrack Cube4D

    FDA UDI
    Fiagon GmbH·04260759930058·Navigation unit, Component of RIWOtrack Navigat...

    RIWOtrack Cube4D

    FDA UDI
    Fiagon GmbH·04260759931567·Navigation unit, Component of RIWOtrack Navigat...

    ANATOMIC SHOULDER PROSTHESIS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·May 23, 2025

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 14, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 8, 2011

    TENDRIL SDX

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

    BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·September 3, 2021

    Lysus Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus Infusion System consists of three main components, a single use Lysus Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus Infusion Catheter System.

    FDA Recall
    Terminated ·Ekos Corp·Product code KRA·November 22, 2004

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014