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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
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17 records meeting your search criteria returned- Product Code: OBJ Product Problem: Device Operates Differently Than Expected Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
ARROW TELEFLEX 03/28/2018
BIOSENSE WEBSTER INC. SOUNDSTAR 09/18/2017
INFRAREDX, INC. TVC INSIGHT CATHETER HYDROPHILIC 06/06/2017
BIOSENSE WEBSTER, INC. (IRWINDALE) SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATH 05/24/2017
BIOSENSE WEBSTER, INC. (IRWINDALE) SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATH 05/23/2017
VOLCANO CORPORATION EAGLE EYE 03/24/2017
TELEFLEXMEDICAL ARROW 12/29/2016
BIOSENSE WEBSTER INC. SOUNDSTAR ECO 10/14/2016
BOSTON SCIENTIFIC OPTICROSS 08/10/2016
BOSTON SCIENTIFIC OPTICROSS CORONARY IMAGING CATHETER 08/10/2016
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