BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    LUMATAG(TM) LH DIAGNOSTIC KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INTERFACE ACETABULAR CUP LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLAGEN WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    UNK

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014

    SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 30, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 8, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FNL·November 12, 2010

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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