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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
 

 
 
4 records meeting your search criteria returned- Product Code: DSI Product Problem: Manufacturing, Packaging or Shipping Problem Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
BIOTEL / CARDIONET MCOT MOBILE CARDIAC OUTPATIENT TELEMETRY 08/13/2019
MEDTRONIC EUROPE SARL REVEAL LINQ 08/01/2018
MEDTRONIC EUROPE SARL REVEAL LINQ 06/08/2017
MEDTRONIC PUERTO RICO OPERATIONS CO. REVEAL XT 08/09/2016
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