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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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193 records meeting your search criteria returned- Product Code: DWJ Product Problem: Therapeutic or Diagnostic Output Failure Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 03/14/2019
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 03/14/2019
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 03/14/2019
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM 03/13/2019
MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 11/14/2018
3M HEALTH CARE 3M¿ BAIR HUGGER¿ FULL ACCESS UNDERBODY W 01/30/2018
3M HEALTH CARE 3M BAIR HUGGER¿ FULL ACCESS UNDERBODY BL 01/11/2018
DYMAX CORP. -2523003 ARTIC SUN 5000, 115V NA 06/04/2017
DYMAX CORP. -2523003 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM 12/22/2016
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9 UNKNOWN ARCTICGEL PADS 12/20/2016
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