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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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378 records meeting your search criteria returned- Product Code: FZX Product Problem: Material Deformation Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
SYNTHES GMBH 2.4MM/1.8MM DOUBLE DRILL SLEEVE 06/15/2023
SYNTHES GMBH MATRIXMANDIBLE THREADED TROCAR DRILL GUI 06/07/2023
DEPUY MITEK LLC US SAWTOOTH DRILL GUIDE 05/30/2023
DEPUY MITEK LLC US RESTORE TIBIAL GUIDE/RATCHET, ±10% 05/23/2023
DEPUY MITEK LLC US RESTORE TIBIAL GUIDE/RATCHET, ±10% 05/23/2023
SYNTHES GMBH ALIGNMENT ROD 05/01/2023
SYNTHES GMBH ALIGNMENT ROD 05/01/2023
SYNTHES GMBH TROCAR Ø1.6 Ø4.5 04/24/2023
ZIMMER BIOMET, INC. PATELLA REAMER INSETTING GUIDE WITH COAT 04/18/2023
SYNTHES GMBH OUTER SLEEVE FOR INSERTION GUIDE 04/17/2023
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