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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience
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14 records meeting your search criteria returned- Product Code: MCW Product Problem: Off-Label Use Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 11/03/2023
CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 ORBITAL ATHERECTOMY SYSTEM 05/17/2023
UNKNOWN ROTAREX 05/03/2023
CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 ORBITAL ATHERECTOMY SYSTEM 01/20/2023
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 05/20/2022
UNKNOWN ROTAREX 10/04/2021
UNKNOWN ROTAREX 09/23/2021
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK EXCHANGEABLE SERIES PERIPHER 06/28/2021
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 06/10/2021
EXIMO MEDICAL LTD. CATHETER EXIMO ATHERECTOMY 12/28/2020
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