BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    MTS Levofloxacin 0.002 - 32 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Pulmonary Function Test Kit B, 33mm VBMAX

    FDA UDI
    A-M SYSTEMS, LLC·00817081027693·Pulmonary Function Test Kit B, Disposable, Qty ...

    mambo™ modular cervical plate system

    FDA UDI
    Ulrich GmbH & Co. KG·04052536164387·mambo bone screw, self-drilling, violet, Ø 3.5 ...

    PRODIGY DIABETES MANAGEMENT SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    BIPOLAR HEAD Ø28X46

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWY·January 16, 2019

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 14, 2025

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 17, 2014

    2520274-2013-03624

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·June 21, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 28, 2011

    MIDAS REX MR8

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025

    MOTOR MR8 ELECTRIC

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 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