BEUDAMED
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    ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033802·Baltic Denture System BDLoad BDLoad Mn7 PLSEbi...

    HYSTEROSCOPES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FRC POSTEC

    FDA 510(k)
    FDA Class 1 ·Dental

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·July 20, 2007

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·March 29, 2007

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·July 20, 2007

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·March 29, 2007

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 3, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 23, 2011

    ALUMINUM CRUTCHES WITH ACCESSORIES

    FDA Adverse Event
    Malfunction ·DRIVE MEDICAL DESIGN AND MFG·Product code IPR·April 22, 2008

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024