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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
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24 records meeting your search criteria returned- Product Code: MCW Product Problem: Material Twisted/Bent Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECT 10/25/2021
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 08/20/2021
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 03/01/2021
EXIMO MEDICAL LTD. CATHETER EXIMO ATHERECTOMY 12/28/2020
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 11/12/2020
AVINGER INC. PANTHERIS 10/21/2020
AVINGER INC. PANTHERIS SV 11/11/2019
MEDTRONIC IRELAND HAWKONE 6FR 09/04/2019
AVINGER INC. PANTHERIS SV 08/07/2019
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC 04/26/2019
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