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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
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11 records meeting your search criteria returned- Product Code: GWQ Product Problem: Overheating of Device Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
NIHON KOHDEN CORPORATION PSG-1100A 08/21/2021
NIHON KOHDEN CORPORATION PSG-1100A 08/21/2021
NATUS MEDICAL INCORPORATED EMU40EXQ BREAKOUT BOX 07/28/2021
NATUS MEDICAL INCORPORATED EMU40EX BASE UNIT 10/29/2020
NATUS MEDICAL INC. DBA EXCEL-TECH LTD (X EMU40 06/26/2020
NATUS MEDICAL INC. DBA EXCEL-TECH LTD (X EMU40 06/26/2020
NATUS MEDICAL INC. DBA EXCLE-TECH LTD (X CONNEX BRAIN MONITOR BREAKOUT BOX 06/14/2019
VYAIRE MEDICAL INC. STANDARD POLYSOMNOGRAPHY WITH ELECTROENC 01/25/2019
VYAIRE MEDICAL INC STANDARD POLYSOMNOGRAPHY WITH ELECTROENC 01/25/2019
NATUS MEDICAL INC. DBA EXCLE-TECH LTD (X EMU40 08/12/2016
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