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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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80 records meeting your search criteria returned- Product Code: LIT Product Problem: Material Puncture/Hole Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHET 03/30/2022
COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHET 02/14/2022
COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHET 01/28/2022
BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON 01/20/2022
BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 3/200/130 01/05/2022
BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2.5/150/130 12/14/2021
CORDIS CORPORATION SABER 2.5MM25CM 150 12/08/2021
CORDIS CORPORATION POWERFLEXPRO 10MM4CM 80 11/22/2021
COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHET 10/25/2021
BARD PERIPHERAL VASCULAR, INC. DORADO 09/17/2021
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