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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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17 records meeting your search criteria returned- Product Code: PRC Patient Problem: No Consequences Or Impact To Patient Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION C 10/01/2020
LUTONIX, INC LUTONIX 035 DRUG COATED BALLOON PTA CATH 08/26/2020
LUTONIX, INC LUTONIX DRUG COATED BALLOON 07/23/2020
LUTONIX, INC LUTONIX DRUG COATED BALLOON 04/08/2020
LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATATION 03/19/2020
LUTONIX, INC LUTONIX 035 DRUG COATED BALLOON PTA CATH 03/16/2020
C.R. BARD, INC. (GFO) LUTONIX 035AV DRUG COATED BALLOON PTA CA 06/24/2019
C.R. BARD, INC. (GFO) LUTONIX 035AV DRUG COATED BALLOON PTA CA 03/07/2019
C.R. BARD, INC. (GFO) LUTONIX 035AV DRUG COATED BALLOON PTA CA 12/26/2018
C.R. BARD, INC. (GFO) LUTONIX 035AV DRUG COATED BALLOON PTA CA 12/18/2018
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