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    SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HAMILTON-T1

    FDA Adverse Event
    Injury ·HAMILTON MEDICAL AG·Product code CBK·March 17, 2026

    ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HF SENSOR DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code MOM·May 7, 2026

    ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INTELLIVUE TELEMETRY SYSTEM

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 27, 2018

    HAMILTON-T1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·March 9, 2026

    ESSENTIO MRI DR

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWP·June 20, 2019

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Injury ·PHILIPS NORTH AMERICA LLC·Product code MKJ·May 26, 2021

    ZIO AT

    FDA Adverse Event
    Malfunction ·IRHYTHM TECHNOLOGIES, INC·Product code DSI·October 18, 2022

    EZ WIDER BARIATRIC BED

    FDA Adverse Event
    Injury ·KREG MEDICAL·Product code OSI·July 15, 2025

    Hospital Continuous Glucose Monitoring System

    FDA classification
    FDA Class 2 ·Hospital Continuous Glucose Monitoring System

    Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX4O is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX4O does not automatically provide local monitoring or alarming when connected to the Information Center.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 12, 2017

    PANORAMA

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code DRT·September 29, 2008

    LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF 11996-000520 The LIFEPAK¿ 15 Monitor/Defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. RD rainbow" 8¿ SpCO sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO¿), and methemoglobin saturation (SpMet¿) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·February 26, 2025

    Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients. It provides secondary operator notification of alarms from other networked medical devices. It provides for the retrospective review of alarm conditions, physiologic waves and parameters from multiple patients. The intended use of the printer, when present, is to provide hardcopy text, graphics, and wave data. The Efficia CMS200 may provide for connection and information exchange to external systems. The Efficia CMS200 is intended for use in hospitals and out of hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·March 1, 2017

    Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·December 7, 2016

    SPACELABS ULTRAVIEW SL PATIENT MONITOR

    FDA Adverse Event
    Other ·SPACELABS HEALTHCARE·Product code DSI·November 11, 2010

    PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. ¿ -With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. -With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units

    FDA Enforcement
    Class II ·Terminated·GETINGE US SALES LLC·July 31, 2019