BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ATEC IOM Accessory Instruments

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Oticon

    FDA UDI
    Oticon A/S·05707131331403·OPN 2, KIT 13 2.4G NFM L C001

    SimpliCore

    FDA UDI
    Kerr Corporation·00195062153464·Kerr SimpliCore Obturator for ZenFlex ONE Size ...

    TRAUSON GENERAL SPINAL SYSTEM (GSS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUDIT MICROCV CARDIAC MARKERS LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

    LINER: MPACT FLAT PE HC LINER 36/G

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·September 15, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    S-ROM M HEAD 36MM +0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 21, 2013

    *

    FDA Adverse Event
    SIERRA SCIENTIFIC INSTRUMENTS·Product code FFX·July 15, 2011

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 Inc.·July 11, 2018

    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