BEUDAMED
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    ET IV SA Dental Implants

    FDA 510(k)
    FDA Class 2 ·Dental

    PLASTIC INNER TRAY

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896019461·PLASTIC INNER TRAY WITH METAL CLASPS LOWER MAT

    NEUROSIGN AVALANCHE MOTOR NERVE MONITOR

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    REDSENSE-ALARM UNIT AND SENSOR

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

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·December 2, 2019

    MDA ASSEMBLY

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 21, 2013

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·July 28, 2011

    ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;

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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024