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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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422 records meeting your search criteria returned- Product Code: KRA Report Date From: 1/1/2019 Report Date To: 12/31/2019

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ManufacturerBrand NameDate Report Received
BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO FATHOM SYSTEM 10/14/2019
BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO FATHOM-16 SYSTEM 10/11/2019
COOK INC CXI SUPPORT CATHETER 10/10/2019
MICRO THERAPEUTICS, INC. DBA EV3 MARATHON 10/10/2019
COOK INC TRIFORCE¿ PERIPHERAL CROSSING SET 10/08/2019
BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO FATHOM SYSTEM 10/07/2019
CODMAN AND SHURTLEFF, INC MICROCATHETER 10/07/2019
COOK INC CXI SUPPORT CATHETER 10/03/2019
EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER 10/03/2019
EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER 10/03/2019
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