BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890102960·Zirlux Titanium Abutment 3 mmH compatible with:...

    Silverbolt/Mainframe

    FDA UDI
    Choice Spine, LP·00840996175005·SILVERBOLT,ML,ROD,STRAIGHT,TI,5.5X100

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036007331·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102060·Shaver, Open, 6mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023895·PADDLE SPREADER, 6MM

    SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    STARION CAUTERY HOOK

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

    QUICK COMBO PAD

    FDA Adverse Event
    Injury ·PHYSIO CONTROL CORP.·Product code MLN·January 17, 1997

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·February 1, 2018

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    AMS SPHINCTER 800 URINARY PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code EZY·March 12, 2013

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 1, 2011

    CODMAN BACTISEAL EVD CATHETER

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·October 5, 2018

    CODMAN BACTISEAL EVD CATHETER

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·October 5, 2018

    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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013