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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: ONU Product Problem: Material Split, Cut or Torn Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION C 11/08/2021
LUTONIX, INC LUTONIX 035 DRUG COATED BALLOON PTA CATH 03/16/2020
C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATH 04/19/2019
MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA B 04/16/2019
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