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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
 

 
 
9 records meeting your search criteria returned- Product Code: DSI Product Problem: Thermal Decomposition of Device Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
BRAEMAR MANUFACTURING, LLC C6 MCOT PPM 12/18/2023
BRAEMAR MANUFACTURING, LLC C6 MCOT PPM 09/25/2023
BRAEMAR MANUFACTURING, LLC C6 MCOT PPM 09/12/2023
BRAEMAR MANUFACTURING, LLC C6 MCOT 01/17/2023
BRAEMAR MANUFACTURING, LLC UNIT, C6M, A10E 12/15/2022
BRAEMAR MANUFACTURING, LLC UNIT, C6M, A10E 12/15/2022
BRAEMAR MANUFACTURING, LLC UNIT, C6M, A10E U 11/24/2022
GE MEDICAL SYSTEMS INFORMATION TECHNOLOG CIC PRO 05/26/2021
INFOBIONIC INC. MOME KARDIA 08/11/2020
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