BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Disposable Mouthpiece 27mm OD

    FDA UDI
    Vacumed·00850644007312·cardboard mouthpiece

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193022783·B-P HIP ACETABULAR BEARING - 32 MM I.D. X 50 MM...

    GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FMP METAL/METAL ACETABULAR INSERT

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·May 5, 2023

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FRN·February 27, 2013

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIV.·Product code LGW·February 15, 2011

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·March 31, 2008

    Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 17, 2019

    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