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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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7 records meeting your search criteria returned- Product Code: LPB Product Problem: Leak/Splash Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
BIOSENSE WEBSTER, INC. THERMOCOOL SMARTTOUCH SF ABLATION CATHET 06/06/2023
MEDTRONIC, INC. CRYOCONSOLE 01/17/2023
MEDTRONIC CRYOCATH LP CRYOCONSOLE 09/01/2022
BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH SF 08/24/2022
BIOSENSE WEBSTER INC. THERMOCOOL SMARTTOUCH STSF 08/04/2022
MEDTRONIC, INC. MEDTRONIC CRYOCONSOLE 12/13/2021
BIOSENSE WEBSTER INC. THERMOCOOL SMARTTOUCH SF 11/02/2021
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