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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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72 records meeting your search criteria returned- Product Code: DRF Product Problem: Device Contamination with Chemical or Other Material Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
BIOSENSE WEBSTER INC LASSO NAV 2515,22P SPLITHANDLE 05/16/2019
BIOSENSE WEBSTER INC LASSO® NAV ECO VARIABLE CATHETER 09/10/2018
BIOSENSE WEBSTER INC COOLFLOW TUBING SET,SINGLE PK 08/31/2018
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLAMAP ORION¿ 04/18/2018
BIOSENSE WEBSTER INC COOLFLOW TUBING SET 03/12/2018
ARDEN HILLS, MN INTELLAMAP ORION¿ 12/20/2017
BIOSENSE WEBSTER, INC. (IRWINDALE) COOLFLOW TUBING SET 07/18/2017
BIOSENSE WEBSTER, INC. (IRWINDALE) CATHETER, ELECTRODE RECORDING 06/22/2017
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) EP¿XT¿ UNIDIRECTIONAL STEERABLE DIAGNOST 06/22/2017
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLAMAP ORION¿ 05/18/2017
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