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

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    AUSTIN MODIFIED PARTIAL OSSICULAR RE-

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ILS·May 21, 2014

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code LRK·October 29, 2012

    LAPAR COAGULATING SHEAR, 15MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GEI·January 16, 2008

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012