6 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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4.5 BROAD SCP PLT 26-H STER
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 13, 2016
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2020
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·March 4, 2015
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.
FDA Enforcement
Class II
·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012