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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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16 records meeting your search criteria returned- Product Code: ONU Product Problem: Device-Device Incompatibility 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 02/01/2023
LUTONIX, INC LUTONIX 018 DRUG COATED DILATATION CATHE 11/14/2022
BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CAT 11/04/2022
LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION C 04/04/2022
LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION C 04/04/2022
BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CAT 02/10/2022
LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION C 11/15/2021
LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION C 10/01/2021
LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION C 04/26/2021
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