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

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    SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·November 2, 2012

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306830426·Weinstein instrument stringer, 15.25 x 6.3cm (6...

    uNion MAX

    FDA UDI
    Ulrich Medical Usa, Inc.·00810076334721·High Angulation Plate, 3-Level, 69 mm

    DURABOND NON-PRECIOUS CERAMIC ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    MAINFRAME 8253001IP RESPONSE 2.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·April 2, 2013

    EDWARDS MC3 TRICUSPID ANNULOPLASTY RING

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·March 25, 2011

    T3 MOD REV DIST STM 15MMX225MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code LZO·April 15, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021