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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
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89 records meeting your search criteria returned- Product Code: ONU Product Problem: Material Twisted/Bent Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
LUTONIX, INC LUTONIX 018 DRUG COATED DILATATION CATHE 02/29/2024
MEDTRONIC IRELAND IN.PACT 018 PACLITAXEL-COATED PERCUTANEO 02/08/2024
MEDTRONIC IRELAND IN.PACT PACIFIC 01/17/2024
LUTONIX, INC LUTONIX 018 01/11/2024
LUTONIX, INC LUTONIX 018 01/09/2024
LUTONIX, INC LUTONIX 014 RX SFA DRUG COATED BALLOON D 09/25/2023
MEDTRONIC IRELAND IN.PACT AV ACCESS 09/08/2023
LUTONIX, INC LUTONIX 018 DRUG COATED DILATATION CATHE 08/06/2023
MEDTRONIC IRELAND IN.PACT AV ACCESS 08/02/2023
MEDTRONIC IRELAND IN.PACT PACIFIC 05/02/2023
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