BEUDAMED
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    DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT

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

    DHF 06 HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALY·Product code KDI·May 22, 2025

    DRX - Ascend System

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971021731·DRX-ASCEND SYSTEM/QG-65-R10-T600

    INTEGRAPH FLASH, MODEL CI 110

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SS MATRIX

    FDA 510(k)
    FDA Unclassified ·Unknown

    UNKNOWN SOLITAIRE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR·Product code NRY·July 5, 2022

    REBAR

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR·Product code KRA·July 5, 2022

    REBAR

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR·Product code KRA·July 5, 2022

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·March 26, 2013

    SIGMA SPECTRUM SMART PUMP

    FDA Adverse Event
    Malfunction ·SIGMA INTL·Product code FRN·March 14, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·March 19, 2008

    UNKNOWN SOLITAIRE

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR·Product code NRY·July 5, 2022

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014