4 results
·
11ms
·
Sources: EU EUDAMED, US FDA
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
FDA Enforcement
Class II
·Completed·SynCardia Systems LLC·November 1, 2023
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
FDA Enforcement
Class I
·Completed·Empowered Diagnostics LLC·February 9, 2022
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
FDA Enforcement
Class I
·Completed·Empowered Diagnostics LLC·February 9, 2022
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
FDA Enforcement
Class II
·Completed·Basic Reset Inc.·November 20, 2019