BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

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    OTC Combo TENS/EMS System

    FDA 510(k)
    FDA Class 2 ·Neurology

    n/a

    FDA UDI
    Ortho Development Corporation·00822409108084·Cement Only Broach Size 9

    BLUE MOUNTAIN CERVICAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Advin Multi-Drug Screen Test Cassette, Dip Card and Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 17, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

    INSTINCT ENDOSCOPIC HEMOCLIP

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code PKL·July 19, 2021

    INSTINCT ENDOSCOPIC HEMOCLIP

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2022

    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