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

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    Filters Regulation: Us FDA ×

    MODIFICATION TO ACIST CL 100H

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACIST

    FDA Adverse Event
    Malfunction ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007

    Parkell Desensitizer Gel

    FDA 510(k)
    FDA Class 2 ·Dental

    GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCESSORIES

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 6, 2013

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014

    ELCA LASER SHEATH

    FDA Adverse Event
    Injury ·SPECTRANETICS CORP.·Product code LPC·February 11, 2011

    AIA-900

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code KHO·February 24, 2016

    INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·February 27, 2024

    INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·March 21, 2024

    TOSOH AIA-900

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code KHO·December 13, 2016

    A1A-600II

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code KHO·October 28, 2016

    TOSOH AIA-1800

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code KHO·November 11, 2016

    AIA-360

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code KHO·March 3, 2016

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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