BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Lifeshield

    FDA UDI
    ICU Medical, Inc.·10887787005377·LIFESHIELD, Primary Blood Set, 200 Micron Filte...

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00887709044081·Maximizer™ Set with Backcheck Valve

    KLARITY MEDICAL

    FDA UDI
    Klarity Medical Products, LLC·00817355028739·Klarity Sol™ S-type Head Mask, 36% perforation,...

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00810030810247·Femoral Head, 36mm, 0mm, Ceramic

    KLARITY MEDICAL

    FDA UDI
    Klarity Medical Products, LLC·00817355028975·Klarity Sol™ S-type Head and Shoulder Mask, 36%...

    U-Lite

    FDA 510(k)
    FDA Class 2 ·Radiology

    Innova Nasal Non-Vented Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·November 11, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 24, 2011

    ECHELON*FLEX60 ARTICULATING

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 2013

    2.7 DEGREE STRAIGHT SAGITAL SAW

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 15, 2019

    3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HTW·May 16, 2017

    3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HTW·August 31, 2017

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021