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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
MEDTRONIC IRELAND SILVERHAWK BTK 10/23/2020
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 10/22/2020
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER 10/22/2020
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC 10/22/2020
MEDTRONIC, INC. HAWKONE MADE BY MEDTRONIC DIRECTIONAL AT 10/21/2020
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTO 10/21/2020
AVINGER INC. PANTHERIS 10/21/2020
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTO 10/21/2020
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 10/20/2020
BOSTON SCIENTIFIC CORPORATION JETSTREAM ATHERECTOMY CATHETER 10/20/2020
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