BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

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    AOS Galileo™ Trochanteric Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112649·BARRON CORNEAL PUNCH 8.25MM

    SprintRay High Impact Denture Base - Dark Pink

    FDA UDI
    Sprintray, Inc.·00850039704406·SprintRay High Impact Denture Base is a light-c...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112526·BARRON VACUUM TREPHINE 8.25MM

    S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KINAIR

    FDA Adverse Event
    Malfunction ·KCI USA, INC.·Product code IOQ·October 16, 2008

    ENTRUST AT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

    PI PICC KIT: 4 FR X 50 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code LJS·June 27, 2013

    INJECTOR LOCKING N40-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021

    TRIMA ACCEL

    FDA Adverse Event
    Injury ·TERUMO BCT·Product code GKT·August 12, 2020

    INJECTOR LOCKING N40-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 21, 2021

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·June 8, 2020

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021