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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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110 records meeting your search criteria returned- Product Code: MCW Patient Problem: Embolism Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
MEDTRONIC IRELAND SILVERHAWK 12/11/2019
MEDTRONIC IRELAND TURBOHAWK 12/11/2019
BOSTON SCIENTIFIC CORPORATION JETSTREAM SC ATHERECTOMY CATHETER 11/26/2019
MEDTRONIC IRELAND HAWKONE 6F 11/20/2019
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 10/08/2019
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER 09/05/2019
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC 08/22/2019
CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 PERIPHERAL ORBITAL ATHERECTO 08/16/2019
BOSTON SCIENTIFIC CORPORATION JETSTREAM XC 07/30/2019
CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHER 07/22/2019
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