BEUDAMED
    15 results · 24ms · Sources: EU EUDAMED, US FDA

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    Vevazz LED

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDICAL MAGNETIC TAPE RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 3, 2025

    U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·October 31, 2022

    U BY KOTEX : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·January 5, 2022

    U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·BERRY PLASTICS QINGDAO LTD.·Product code HEB·June 28, 2023

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·December 7, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 30, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·September 8, 2020

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 11, 2013

    COLLEAGUE PRE P1.7

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

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 18, 2008

    Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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