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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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7 records meeting your search criteria returned- Product Code: ONU Product Problem: Difficult to Insert Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
LUTONIX, INC LUTONIX 018 DRUG COATED DILATATION CATHE 06/25/2023
LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION C 02/23/2023
BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CAT 03/18/2022
LUTONIX, INC LUTONIX 018 DRUG COATED DILATATION CATHE 01/04/2022
MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA B 04/21/2021
SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLA 08/11/2020
C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATH 02/13/2019
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