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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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94 records meeting your search criteria returned- Product Code: LIT Product Problem: Fluid/Blood Leak Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
CREAGH MEDICAL LTD. DYNAMIS AV 08/14/2020
COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHET 08/05/2020
BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 3/150/130 04/23/2020
COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHET 04/14/2020
BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 7/40/90 03/03/2020
COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHET 01/30/2020
COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHET 01/29/2020
COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHET 01/27/2020
BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/120/150 12/13/2019
COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHET 10/03/2019
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