BEUDAMED
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    MYLABSEVEN, MYLABALPHA

    FDA 510(k)
    FDA Class 2 ·Radiology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756614542·Knee Immobilizer

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694026482·MFx Angulated Locking Curved Plate, 7 Hole

    INTREPED, Intraosseous Fusion Device

    FDA UDI
    Auxano Medical LLC·00850055649590·INTREPED 08 Drill- Universal Stop

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828195706·

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828195638·

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828195515·

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828195683·

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828194785·

    GLIDESHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRAVISUAL

    FDA 510(k)
    FDA Class 2 ·Radiology

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018

    VAP ENDOTRACHEAL TUBES

    FDA Adverse Event
    Malfunction ·HALYARD HEALTH·Product code BTR·July 6, 2017

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 28, 2011

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 31, 2014

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019

    Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.

    FDA Enforcement
    Class III ·Terminated·Mindray DS USA, Inc. dba Mindray North America·April 4, 2018

    PINNACLE MTL INS NEUT36IDX56OD (DOI: 3/14/2006 - DOR 3/14/2008)

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·December 17, 2012