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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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40 records meeting your search criteria returned- Product Code: LIT Product Problem: Material Puncture / Hole Report Date From: 01/1/2014
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ManufacturerBrand NameDate Report Received
KANEKA CORPORATION PTA BALLOON CATHETER S4, JACKAL RX 01/11/2018
KANEKA CORPORATION PTA BALLOON CATHETER(OHICHO3) 12/25/2017
KANEKA CORPORATION SENRI EX 12/25/2017
CORDIS CORPORATION POWERFLEXPRO 10MM4CM 80 10/04/2017
BIOTRONIK AG PASSEO-18 2/60/90 03/03/2017
CORDIS DE MEXICO AVIATOR PLUS .014 5.0X30 142CM 01/06/2017
CORDIS DE MEXICO SABER 5MM6CM 150 11/22/2016
CORDIS CORPORATION SABER PTA DILATATION CATHETER 03/17/2016
CORDIS CORPORATION SABER PTA DILATATION CATHETER 08/18/2015
BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA BALLOON DILATATION CAT 05/27/2015
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