BEUDAMED
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    KSEA FIBERSCOPE

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

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040012208·Zirlux 16+ A3 95X20

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450238042·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033328828·

    BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·September 3, 2025

    OXYLOG 1000, MODEL 2M86840

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SYNTHES SCALLOPED DISTAL TIBIA PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·March 19, 2013

    SUPER POLIGRIP (ULTRA FRESH & EXTRA CARE)

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

    DURA 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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014