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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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95 records meeting your search criteria returned- Product Code: LON Patient Problem: No Patient Involvement Report Date From: 01/1/2018
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ManufacturerBrand NameDate Report Received
BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX AST INDICATOR SOLUTION 02/11/2021
BIOMERIEUX, INC. VITEK 2 AST-P631 TEST 01/15/2021
BIOMÉRIEUX, INC VITEK 2 AST-GP75 TEST KIT 01/04/2021
BIOMERIEUX INC. VITEK 2 AST-GP75 TEST KIT 12/22/2020
BIOMÉRIEUX, INC. DENSICHEK PLUS 12/18/2020
BIOMÉRIEUX, INC VITEK 2 AST-GP67 TEST KIT 12/02/2020
BIOMERIEUX, INC. VITEK 2 AST-P637 TEST KIT 11/26/2020
BIOMÉRIEUX, INC. VITEK 2 AST-GP75 TEST KIT 09/28/2020
BIOMÉRIEUX, INC. VITEK 2 AST-GP75 TEST KIT 09/10/2020
BIOMERIEUX, INC. VITEK 2 AST-GP78 TEST KIT 09/01/2020
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