BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    Keos Lumbar IBFD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REMINGTON I-LIGHT HAIR REMOVAL SYSTEM

    FDA Adverse Event
    Injury ·SHASER INC·Product code ONF·May 21, 2021

    AFFIITY CP CENTRIFUGAL BLOOD PUMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOGRAPH 64 AND BIOGRAPH 40

    FDA 510(k)
    FDA Class 2 ·Radiology

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 10, 2013

    TALENT STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 6, 2011

    CENTRICITY RA1000

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE INTEGRATED IT SOLUTIONS·Product code LLZ·September 1, 2008

    Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.

    FDA Enforcement
    Class III ·Ongoing·Alcon Research LLC·November 27, 2024