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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
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18 records meeting your search criteria returned- Product Code: ONU Patient Problem: Unspecified Infection Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLA 05/12/2020
SPECTRANETICS STELLAREX 0.014 OTW DRUG-COATED ANGIOPLA 02/03/2020
SPECTRANETICS STELLAREX 0.014 OTW DRUG-COATED ANGIOPLA 02/01/2020
SPECTRANETICS STELLAREX 0.014 OTW DRUG-COATED ANGIOPLA 02/01/2020
MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA B 09/17/2018
MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA B 07/06/2017
LUTONIX INC. LUTONIX 035 DRUG COATED BALLOONO PTA CAT 07/15/2015
LUTONIX INC. LUTONIX 035 DRUG COATED BALLOON PTA CATH 07/15/2015
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