BEUDAMED
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    DATEX-OHMEDA HMEF 500

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Safco FG Diamonds

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310212653·FG Diamond 836-014 cylinder flat end coarse 5/pack

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854004937·ULTRAPOWER BUR, ROUND DIAMOND (MUSTARD) 5 MM

    ULTRASOUND TRANSDUCER COVER

    FDA 510(k)
    FDA Class 2 ·Radiology

    WELCH ALLYN INSTRUMENT INTERFACE MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GORE® SYNECOR® PREPERITONEAL BIOMATERIAL

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code FTL·July 1, 2022

    ARTICUL/EZE M 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code JDI·March 26, 2013

    EXTENSION SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 17, 2011

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR GALWAY·Product code NIM·March 28, 2008

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code NGT·October 9, 2023

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·October 4, 2023

    CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL 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·April 6, 2016

    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