BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    KERALLOY NON-GAMMA 2 AMALGAM

    FDA 510(k)
    FDA Class 2 ·Dental

    EARLOGIC OAE TESTER

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

    MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLEXION PACING LEAD

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DTB·November 18, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 14, 2014

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·December 5, 2012

    Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012

    Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012

    Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012

    Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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