BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    Accula Flu A/Flu B Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331143489·tissue forceps, standard pattern, serrated hand...

    AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERFORATOR DRIVER W/HUDSON END

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 14, 2014

    2520274-2013-03390

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code MOQ·June 15, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011

    BD INTIMA-II 24GAX0.75IN PRN SLM

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·March 11, 2025

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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