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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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297 records meeting your search criteria returned- Product Code: DXN Product Problem: Incorrect, Inadequate or Imprecise Resultor Readings Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
EDWARDS LIFESCIENCES EV1000 PUMP UNIT 10/05/2021
WITHINGS S.A. BP CONNECT 07/12/2021
SPACELABS HEALTHCARE (WASHINGTON), INC ULTRAVIEW 03/30/2021
EDWARDS LIFESCIENCES DR FINGER CUFF 03/29/2021
Unknown Manufacturer NOVA 03/22/2021
MEDLINE INDUSTRIES INC. MEDLINE 03/01/2021
QUALITY PERFORMANCE LTD. KORE TRAK 02/24/2021
OMRON HEALTHCARE, INC. OMRON 3 SERIES UPPER ARM BLOOD PRESSURE 01/12/2021
Unknown Manufacturer AUTOMATIC B/P MONITOR 09/01/2020
Unknown Manufacturer AUTOMATIC B/P MONITOR 09/01/2020
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