BEUDAMED
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    CEDARA I-SOFTVIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    C3 ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 15, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 27, 2013

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 17, 2011

    IAB: 8 FR - 40CC

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·March 28, 2008

    ONX MITRAL CONFORM 25/33

    FDA Adverse Event
    Injury ·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·August 1, 2022

    PFNA Ø10 LONG R 130° L360 TAN

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code HSB·February 15, 2017

    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