BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATHOS LASER

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

    Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·January 2, 2013

    ACCESS(R) THYROXINE ASSAY CALIBRATOR

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code KLI·November 3, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 27, 2013

    TORNIER

    FDA Adverse Event
    Malfunction ·TORNIER INC.·Product code JWH·March 11, 2011

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008

    Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JIS·July 27, 2011

    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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018