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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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10 records meeting your search criteria returned- Product Code: KRA Product Problem: Crack Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
MEDOS INTERNATIONAL SARL PRESHAPED PROWLER14 45TIP 2MRK 07/23/2021
COOK INC TRIFORCE PERIPHERAL CROSSING SET 02/01/2021
MEDOS INTERNATIONAL SARL PROWLER SEL PLUS 150/5CM 45TIP 03/18/2020
CODMAN AND SHURTLEFF, INC PROWLER SELECT LPES J TIP 03/02/2020
CODMAN AND SHURTLEFF, INC PROWLER SELECT LPES 45 DEG TIP 02/19/2020
COOK INC CXI SUPPORT CATHETER 01/02/2020
EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER 09/20/2019
BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI 06/18/2019
BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO 07/20/2018
BOSTON SCIENTIFIC - CORK DIREXION HI-FLO 08/09/2017
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