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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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138 records meeting your search criteria returned- Product Code: DSP Patient Problem: Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA 03/16/2021
ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC 03/10/2021
DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB 02/24/2021
DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB 02/11/2021
DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLUG 02/03/2021
DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON 02/02/2021
DATASCOPE CORP. - MAHWAH CS100 01/08/2021
DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG 12/03/2020
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