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

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    INTEGRIS 3D-RA, RELEASE 4.2

    FDA 510(k)
    FDA Class 2 ·Radiology

    HairCheck-DT (THC)

    FDA UDI
    Quest Diagnostics·00868586000247·HairCheck-DT (THC) is an ELISA test kit used fo...

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10887488447469·STRL DEBRIDEMENT SUTURE TRAY

    Gladstone ALIF Trial Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215045234·

    PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011

    FDA 510(k)
    FDA Unclassified ·Unknown

    PAR 5 ACETABULAR COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COVEREDGE 32

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 3, 2021

    RADICAL

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·April 16, 2015

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·March 26, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·April 5, 2011

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·May 7, 2008

    Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

    FDA Enforcement
    Class II ·Terminated·Ondamed Inc·May 16, 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