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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
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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
HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CO 03/27/2024
HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CO 11/30/2023
HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PU 10/24/2023
THORATEC CORPORATION HEARTMATE 3 03/06/2023
HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CO 02/08/2023
HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CO 01/24/2023
HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PU 12/22/2022
THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, EU 05/10/2022
THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, EU 05/03/2022
THORATEC CORPORATION THORATEC HEARTMATE 3 SYSTEM CONTROLLER 04/25/2022
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