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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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6 records meeting your search criteria returned- Product Code: ONU Patient Problem: Perforation of Vessels Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION C 08/21/2023
BOSTON SCIENTIFIC CORPORATION RANGER 08/15/2023
BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CAT 03/11/2022
BOSTON SCIENTIFIC CORPORATION RANGER 09/27/2021
Unknown Manufacturer RANGER SL 08/18/2021
C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATH 05/06/2019
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