BEUDAMED
    13 results · 24ms · 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.
    Filters Regulation: Us FDA ×

    EXCELSIOR MICROCATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code DQY·April 13, 2010

    EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXCELSIOR MICROCATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code DQY·May 18, 2010

    EXCELSIOR MICROCATHETER

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code DQY·August 2, 2010

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033544853·

    CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    POWERED PATIENT ROTATION BED

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code IKZ·March 20, 2013

    CVC SET: 16 GA X 12

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DQY·February 4, 2011

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQC·March 14, 2008

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012