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

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    HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613035921·Insert Tray, For Microsurgical Instrument Trays...

    INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 2, 2010

    BALFOUR RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896081819·BALFOUR RETRACTOR LARGE SPREAD

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450780749·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450852309·

    HS Barr.Burr,Ø4.0x8.0x125,80k

    FDA UDI
    Bien-Air Surgery SA·17630055507553·

    Arena-L®

    FDA UDI
    SPINEFRONTIER, INC.·00190361005575·Arena-L, Lordotic 10 degrees, 38X28X14

    BALFOUR DELUXE RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896048508·BALFOUR DELUXE RETRACTOR DOUBLE BAR WITH TWO PA...

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FAT CONCENTRATION SYSTEM

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

    INFANT REUSABLE HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 13, 2011

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 8, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014

    OCTRODE LEAD, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2011

    VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Plugs are place in the upper and/or lower horizontal canaliculus. Two plugs are placed into a foam carrier and nitrogen sealed inside a foil pouch. The foil pouch is sent to sterilizer for gamma sterilization. Two sterile pouches are packaged in a box with an IFU.

    FDA Enforcement
    Class III ·Terminated·Lacrimedics Inc·February 18, 2015

    Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018