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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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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
BOSTON SCIENTIFIC CORPORATION BLAZER PRIME HTD 12/23/2020
BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 CONTROLLER 12/21/2020
ST. JUDE MEDICAL, INC. THERAPY ABLATION CATHETER QUADRIPOLAR, M 12/16/2020
ST. JUDE MEDICAL, INC. AMPERE RF ABLATION GENERATOR 12/15/2020
ST. JUDE MEDICAL, INC. SAFIRE BI-DIRECTIONAL ABLATION CATHETER 12/10/2020
ST. JUDE MEDICAL, INC. LIVEWIRE TC ABLATION CATHETER 4 MM TIP U 11/26/2020
BOSTON SCIENTIFIC CORPORATION BLAZER PRIME HTD 11/24/2020
BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL 11/19/2020
BIOSENSE WEBSTER INC. THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY 11/19/2020
BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 POD, 100W 11/19/2020
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