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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
UNKNOWN ROTAREX 04/27/2022
MEDTRONIC IRELAND ATK TURBOHAWK SMOOTH 04/14/2022
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTO 04/13/2022
CARDIOVASCULAR SYSTEMS, INC. VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE 04/01/2022
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 04/01/2022
UNKNOWN ROTAREX 03/31/2022
BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS 03/24/2022
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER 03/23/2022
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTO 03/20/2022
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTO 03/17/2022
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