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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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4 records meeting your search criteria returned- Product Code: FYA Product Problem: Therapeutic or Diagnostic Output Failure Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
JOINTOWN MEDICAL DEVICES GROUP CO., LTD ARUIKON 05/18/2021
EVERWELL MEDICAL SUPPLY, LLC N/A 04/21/2021
CH-CON AAMI 4 SMARTSLEEVE SURG GOWN XL 07/23/2020
HALYARD HEALTH HALYARD GOWN SURG NON-REINFORCED 03/10/2020
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