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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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126 records meeting your search criteria returned- Product Code: LIT Product Problem: Material Puncture/Hole Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHET 02/27/2024
CORDIS CORPORATION SABER035 02/23/2024
BOSTON SCIENTIFIC CORPORATION SYMMETRY 40 02/16/2024
CORDIS US. CORP SABERX RADIANZ 02/06/2024
BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 2/220/150 01/18/2024
BOSTON SCIENTIFIC CORPORATION COYOTE ES 01/10/2024
BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 2/220/150 01/03/2024
COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHET 10/27/2023
CORDIS US. CORP SABER 09/19/2023
COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHET 08/29/2023
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