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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
4 records meeting your search criteria returned- Product Code: PRC Patient Problem: Injury Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATATION 10/28/2019
C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATH 08/02/2018
C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATH 11/22/2017
C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATH 10/26/2017
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