7 results
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26ms
·
Sources: EU EUDAMED, US FDA
LEGREST, ELEVATING
FDA 510(k)
FDA Class 1
·Physical Medicine
Emprint Ablation Visualization Application
FDA 510(k)
FDA Class 2
·Radiology
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 3, 2014
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·October 10, 2012
2010 RACK ELECSYS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·September 21, 2007
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013