BEUDAMED
    8 results · 36ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH

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

    BEAUTIBOND

    FDA 510(k)
    FDA Class 2 ·Dental

    HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

    FDA 510(k)
    FDA Class 2 ·Hematology

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·February 25, 2013

    HEARTSTART FR3 ECG, BASIC BUNDLE, USENG

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 24, 2014

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code LGD·February 9, 2011

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025