BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    F3D Cervical Stand-Alone Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000889579·PLATE 7200087 ATL VISION ELITE 87.5MM

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994624932·PLATE 7200087 ATL VISION ELITE 87.5MM

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040187883·ZIRLUX ML DISC B3 98x22

    blueendo

    FDA UDI
    TROKAMED GmbH·04251303822417·MyTube basic tube, WL 185 mm reusable

    24M - Memphis Light & Gas - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588000077·24M - Memphis Light & Gas - Metal

    SYNTHES CRANIAL PLATES

    FDA 510(k)
    FDA Class 2 ·Dental

    MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RADIAL JAW 3 BIOPSY FORCEPS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FCL·October 15, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 10, 2011

    CAREFLOW

    FDA Adverse Event
    Malfunction ·ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD·Product code FOZ·May 29, 2013

    1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

    iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    FDA Enforcement
    Class II ·Terminated·SynCardia Systems Inc.·January 9, 2013

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014