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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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89 records meeting your search criteria returned- Product Code: JWH Product Problem: Material Separation Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 1-2 9MM 10/23/2018
SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 1-2 9MM 10/22/2018
SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM 10/22/2018
SMITH & NEPHEW, INC. GNS II BICONVEX PAT 23MM 10/04/2018
SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 11MM 09/13/2018
DEPUY ORTHOPAEDICS INC US PFC SIGMA CRVD INSERT SZ5 8MM 09/06/2018
DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL TRAY 08/09/2018
SMITH & NEPHEW, INC. JRNY II CR LOCK FEM IMPLANT IMPACTOR 06/18/2018
CONFORMIS, INC. ITOTAL G2 04/04/2018
SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM 03/28/2018
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