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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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109 records meeting your search criteria returned- Product Code: MCW Product Problem: Difficult to Advance Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 11/09/2018
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC 10/17/2018
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC 08/27/2018
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 05/22/2018
SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CA 12/14/2017
BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER 10/11/2017
SPECTRANETICS SPECTRANETICS TURBO ELITE ATHERECTOMY CA 04/27/2017
SPECTRANETICS SPECTRANETICS TURBO ELITE LASER ABLATION 11/11/2016
SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ABLATION 02/11/2016
CARDIOVASCULAR SYSTEMS INCORPORATED STEALTH 360 ORBITAL ATHERECTOMY SYSTEM 12/04/2015
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