BEUDAMED
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    OPERATING 5 & 1/2 STRAIGH SHARP/BLUNT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Jelco

    FDA UDI
    ICU MEDICAL, INC.·15019517050097·

    DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    MICROTHIN-D1 (MOD. 0620)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    SYMBIQ DCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 16, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·October 25, 2012

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·August 28, 2010

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·December 11, 2019

    SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 2, 2024

    SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260

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