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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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500 records meeting your search criteria returned. The results are incomplete - please narrow your search.

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ManufacturerBrand NameDate Report Received
ARROW INTERNATIONAL LLC REDIGUARD IAB: 8FR 40CC 08/24/2023
ARROW INTERNATIONAL LLC FIBEROPTIX ULTRA 8 IAB: 8FR 30CC 08/09/2023
DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG 07/18/2023
ARROW INTERNATIONAL LLC ULTRA 8 IAB: 8FR 30CC 07/10/2023
ARROW INTERNATIONAL LLC REDIGUARD IAB: 8FR 40CC 07/05/2023
DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB WITH ACCESS 06/28/2023
ARROW INTERNATIONAL, LLC (SUBSIDIARY OF ARROW REDIGUARD IABP CATHETER 06/02/2023
TELEFLEX / ARROW INTERNATIONAL, LLC (SUB AC3 OPTIMUS IABP 05/24/2023
TELEFLEX / ARROW INTERNATIONAL, LLC (SUB AC3 OPTIMUS IABP 05/24/2023
GETINGE / DATASCOPE CORP. INTRA-AORTIC BALLOON PUMP (IABP) 05/23/2023
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