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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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500 records meeting your search criteria returned. The results are incomplete - please narrow your search.

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ManufacturerBrand NameDate Report Received
MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SI 01/25/2023
OMNILIFE SCIENCE INC. APEX KNEE 01/24/2023
MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FL 01/24/2023
CONFORMIS INC. ITOTAL IDENTITY CR 01/20/2023
CONFORMIS INC CONFORMIS ITOTAL IDENTITY CR 01/10/2023
EXACTECH, INC. LOGIC 12/29/2022
CONFORMIS, INC. ITOTAL IDENTITY CR 12/22/2022
MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FL 12/22/2022
MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FL 12/22/2022
CONFORMIS, INC. ITOTAL CR 12/13/2022
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