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

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    Duo Hands-free Breast Pump

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111365881·SKLIT XD ADSN BRN S/GRSP 4.75"

    GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RibFix Blu Thoracic Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMP,TSV,MCOL MG,4.7MM,10M

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 24, 2023

    NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 7 -

    FDA Adverse Event
    Injury ·ZIMMER TRABECULAR METAL TECHNOLOGY·Product code JWH·August 25, 2011

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 11, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025