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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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10 records meeting your search criteria returned- Product Code: DSP Patient Problem: Vessel Or Plaque, Device Embedded In Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC 01/07/2020
ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC 08/08/2019
ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC 07/02/2019
ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC 12/13/2018
ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC 11/16/2018
ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC 09/13/2018
ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC 07/03/2018
ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC 12/14/2017
ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC 04/11/2017
ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC 10/26/2016
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