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

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    ICA1 IONIZED CALCIUM ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIPOSE FAT TRANSFER SYSTEM

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

    OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 23, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·May 26, 2015

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021