BEUDAMED
    20 results · 34ms · Sources: EU EUDAMED, US FDA

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    AT HOME DRUG TEST, MODEL 9083 T

    FDA 510(k)
    FDA Unclassified ·Unknown

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890106460·Zirlux UCLA Plastic Abut N Eng

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964151620·Endo Carry-on Procedure Kit contains Basin, Int...

    I IMAGE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033200476·

    I IMAGE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033200544·

    I IMAGE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033204061·

    I IMAGE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033200520·

    I IMAGE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033200537·

    I IMAGE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033200551·

    I IMAGE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033200568·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100460·ASSEMBLY, CADDIE, CURVED RODS WITH STOPS

    DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE

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

    PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 28, 2023

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 14, 2013

    DERMABOND TOPICAL SKIN ADHESIVE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code MPN·February 24, 2011

    RIATA ST OPTIM PASSIVE FIXATION LEAD

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

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024