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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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144 records meeting your search criteria returned- Product Code: MCW Patient Problem: Vascular Dissection Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
STRAUB MEDICAL AG ROTAREXS 6F 110CM (STRAUB MEDICAL) 04/22/2020
STRAUB MEDICAL AG ROTAREX®S 6F 135CM (STRAUB MEDICAL®) 04/20/2020
MEDTRONIC IRELAND HAWKONE 04/07/2020
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 04/02/2020
MEDTRONIC IRELAND HAWKONE 6FR 02/21/2020
CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 PERIPHERAL ORBITAL ATHERECTO 02/12/2020
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 02/05/2020
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 12/30/2019
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC 12/19/2019
MEDTRONIC IRELAND SILVERHAWK 12/11/2019
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