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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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19 records meeting your search criteria returned- Product Code: OTE Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
FUJIFILM CORPORATION ASPIRE CRISTALLE 07/10/2019
FUJIFILM CORPORATION ASPIRE CRISTALLE 07/10/2019
HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 01/10/2019
HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 09/25/2018
HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D 06/13/2017
HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D 01/31/2017
HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D 10/13/2016
HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D 05/18/2016
HOLOGIC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D 11/18/2015
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