BEUDAMED
    30 results · 58ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·May 13, 2026

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026

    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·October 22, 2025

    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·October 22, 2025

    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·October 22, 2025

    Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·January 15, 2025

    Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·January 15, 2025

    Ultraview SL (UVSL) Command Module, Model 91496

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·May 10, 2023

    Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·June 11, 2014

    91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·August 10, 2016

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·September 10, 2014

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015

    Xhibit Telemetry Receiver, Model: 96280

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

    Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·November 9, 2016

    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·October 1, 2014

    Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·July 23, 2014

    Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 20, 2015

    Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 16, 2016

    The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·April 27, 2016

    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·November 4, 2015