BEUDAMED
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    CORERESTORE 2

    FDA 510(k)
    FDA Class 2 ·Dental

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040012253·Zirlux 16+ B3 95X20

    Honeywell Safety Products USA, Inc.

    FDA UDI
    North Safety de Mexicali, S. de R. L. de C.V.·00821812024462·First Aid Kit containing Medical Devices class ...

    RUSCH CANTOR TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DC TITAN

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    MEDEL S.P.A.·Product code BTI·March 19, 2013

    SUPER POLIGRIP ULTRA FRESH CREAM

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·February 21, 2011

    FIRE STAR RX PTCA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code LOX·March 11, 2008

    Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018

    CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018

    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