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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: DXZ Product Problem: Material Split, Cut or Torn Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
W. L. GORE & ASSOCIATES, INC. GORE PRECLUDE PERICARDIAL MEMBRANE 03/01/2021
W. L. GORE & ASSOCIATES, INC. GORE PRECLUDE PERICARDIAL MEMBRANE 02/08/2021
CRYOLIFE, INC. PHOTOFIX PATCH - 4CM X 4CM GLOBAL 05/15/2019
BARD ACCESS SYSTEMS BARD PTFE FELT 04/19/2019
CRYOLIFE, INC. PHOTOFIX UNKNOWN CONFIGURATION 11/13/2018
CRYOLIFE, INC. ¿ KENNESAW PHOTOFIX UNKNOWN CONFIGURATION 11/13/2018
CRYOLIFE, INC. PHOTOFIX PATCH - 0.8CM X 8CM 07/30/2018
CRYOLIFE, INC. PHOTOFIX PATCH - 0.8CM X 8CM 07/23/2018
CRYOLIFE, INC. PHOTOFIX DECELLULARIZED BOVINE PERICARDI 07/19/2018
CRYOLIFE, INC. PHOTOFIX PATCH - 0.8CM X 8CM 07/03/2018
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