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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: DRA Patient Problem: Heart Block Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
MEDTRONIC IRELAND FLEXCATH CONTOUR¿ STEERABLE SHEATH 03/25/2024
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 06/16/2023
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 06/13/2023
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH 02/23/2023
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH 07/20/2021
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 04/23/2021
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 03/25/2021
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 03/11/2021
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH 01/27/2021
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 12/15/2020
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