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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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93 records meeting your search criteria returned- Product Code: DRA Product Problem: Material Integrity Problem Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 03/26/2021
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 03/04/2021
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 02/24/2021
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 02/12/2021
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH 02/10/2021
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 01/07/2021
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 11/17/2020
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH 11/17/2020
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 10/06/2020
MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH 09/28/2020
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