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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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10 records meeting your search criteria returned- Product Code: DQA Product Problem: Improper Device Output Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
MEDIANA NELLCOR 02/22/2017
GALWAY (RP)-RX NELLCOR 12/16/2016
MASIMO CORPORATION MIGHTYSAT 06/30/2016
SANMINA-SCI SYSTEMS (M) SDN BHD N65P HANDHELD PULSE OXIMETER X1 05/03/2016
COVIDIEN NELLCOR 12/04/2015
MASIMO CORPORATION RAD-5V HANDHELD 07/10/2015
MASIMO CORPORATION RADICAL-7, COLOR SCREEN 09/12/2014
MASIMO CORPORATION RAD-8, HORIZONTAL 08/28/2014
MEDIANA OXIMAX N-560 PULSE OXIMETER 08/20/2014
MASIMO CORPORATION RADICAL-7 COLOR SCREEN HANDHELD 08/06/2014
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