BEUDAMED
    39 results · 24ms · Sources: EU EUDAMED, US FDA

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    ZOLL PROPAQ MD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SleepWeaver Elan - Mask Only - Regular - Blue

    FDA UDI
    CIRCADIANCE, LLC·B036100654·SleepWeaver Elan Cloth Nasal PAP Mask Only - Re...

    VOLKMAN RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896049260·VOLKMAN RETRACTOR SHARP PRONGS

    DEBAKEY VASCULAR CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896002913·DEBAKEY VASCULAR CLAMP ANGLED JAW CURVED SHANK

    DEBAKEY VASCULAR CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921006540·DEBAKEY VASCULAR CLAMP ANGLED JAW CURVED SHANK

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450852309·

    Indus®

    FDA UDI
    SPINEFRONTIER, INC.·00190361001317·Invue Max, Three Level ACP, 54mm

    VBMAX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AT HOME DRUG TEST, MODEL 9078 T

    FDA 510(k)
    FDA Unclassified ·Unknown

    UNKNOWN

    FDA Adverse Event
    Malfunction ·ALPHA MEDICAL·Product code DYB·August 12, 2023

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP·Product code DSP·June 6, 2014

    ALTEON CUP, CLSTR HOLE G6, SIZE 54MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·August 19, 2021

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·May 8, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

    UNKNOWN DEEP BRAIN STIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·May 12, 2011

    Brilliance iCT Computed Tomography X-ray system, Model 728306

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    Brilliance iCT Computed Tomography X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015

    Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

    FDA Enforcement
    Class II ·Terminated·Primus Corporation·November 11, 2020

    Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018