definiens: ) ( collectively, ) . EachMedical Device, as that term is defined in 21 U.S.C. § 321(h ) of the FD&C Act, that is manufactured, tested, distributed and/or marketed by the Company, is being manufactured, tested, distributed and/or marketed by theCompany in material compliance with applicable FDA Law and Regulation, including those relating to : ( A ) goodmanufacturing practices ; ( B ) regulatory approvals or clearances to market Medical Devices in the United States;(C ) investigational studies ; ( D ) labeling ; ( E ) record keeping ; and ( F ) filing of reports to the FDA . The Company hasnot received any notice or communication from the FDA alleging material noncompliance with any applicable FDALaw and Regulation . The Company has no Knowledge of any pending or completed FDA proceedings seeking therecall, withdrawal, suspension or seizure of any Medical Device against the Company . To the Knowledge of theCompany, the Company is not the subject of any current enforcement proceedings by the FDA