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

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    NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033577806·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033577813·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0142150·Trial, TLIF, 32L OB CRV 7Deg, 15mm

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033577820·

    MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CONTOUR PROFILE LASER

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

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MWI·September 9, 2010

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·September 9, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 6, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 12, 2008

    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.

    FDA Enforcement
    Class III ·Terminated·DeVilbiss Healthcare LLC·July 9, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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