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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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8 records meeting your search criteria returned- Product Code: FLS Product Problem: No Audible Alarm Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
CIRCADIANCE, LLC SMART MONITOR 2 08/29/2018
CIRCADIANCE LLC SMARTMONITOR 2 08/11/2015
RESPIRONICS, INC. SMARTMONITOR 2 PS 06/25/2014
RESPIRONICS, INC. SMARTMONITOR 2 PS 06/25/2014
RESPIRONICS, INC. SMARTMONITOR 2 PS 06/25/2014
RESPIRONICS, INC. SMARTMONITOR 2 PS 06/25/2014
RESPIRONICS, INC. SMARTMONITOR 2 PS 06/25/2014
RESPIRONICS, INC. SMARTMONITOR 2 PS 06/25/2014
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