BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    HEMODIALYSIS VENOUS & ARTERIAL SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    A-FIT®

    FDA UDI
    Gc Orthodontics America Inc.·E53581262200001·A-FIT® 1. MOLAR UPR LFT SZ 22

    CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HANDHELD ECG MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN CERMAIC ACETABULAR INLAY

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 6, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    ANEURX STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·August 17, 2010

    Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024