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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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5 records meeting your search criteria returned- Product Code: HKO Product Problem: Device Operates Differently Than Expected Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
TOPCON KR-800S 02/27/2018
ABBOTT MEDICAL OPTICS IDESIGN AWS SYSTEM 07/01/2016
ABBOTT MEDICAL OPTICS WAVESCAN WS1 06/18/2015
ABBOTT MEDICAL OPTICS WAVESCAN WS1 06/18/2015
ABBOTT MEDICAL OPTICS WAVESCAN FOURIER ALGORITHM 12/17/2014
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