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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
 

 
 
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11 records meeting your search criteria returned- Product Code: PRC Product Problem: Device-Device Incompatibility Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATION C 03/29/2024
LUTONIX, INC LUTONIX 035AV DRUG COATED BALLOON PTA CA 07/28/2023
LUTONIX, INC LUTONIX 035 09/07/2022
LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATION C 06/30/2022
LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATION C 05/20/2022
LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATION C 08/30/2021
BARD PERIPHERAL VASCULAR, INC. LUTONIX 035AV DRUG COATED PTA DILATION C 05/21/2021
LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION C 05/03/2021
LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATION C 05/03/2021
LUTONIX, INC LUTONIX DRUG COATED BALLOON 07/23/2020
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