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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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11 records meeting your search criteria returned- Product Code: DWJ Product Problem: Use of Incorrect Control/Treatment Settings Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
BELMONT MEDICAL TECHNOLOGIES CRITICOOL 03/28/2024
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN STAT 11/30/2022
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN STAT 10/07/2022
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 02/09/2022
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 09/03/2021
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN DEVICE 08/03/2021
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 2000 07/31/2020
MEDIVANCE, INC. ¿ 1725056 ARCTICSUN 5000 10/02/2019
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 07/11/2019
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 07/09/2019
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