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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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83 records meeting your search criteria returned- Product Code: DSP Patient Problem: Injury Report Date From: 01/1/2009

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ManufacturerBrand NameDate Report Received
ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC 04/02/2019
ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC 03/27/2019
DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB 03/15/2019
DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB 02/24/2019
ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC 02/04/2019
ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC 12/13/2018
DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG 11/08/2018
ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC 09/21/2018
DATASCOPE MAHWAH CS300 04/10/2018
DATASCOPE MAHWAH CS300 03/05/2018
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