Name | Package Insert | 510(k) Substantial Equivalence Determination Decision Summary |
---|---|---|
MTS™ Lefamulin | rev.0 - 06/04/2020 | ![]() |
MTS™ Ampicillin-sulbactam | rev.0 - 06/12/2019 | ![]() |
MTS™ Imipenem | rev.0 - 04/09/2019 | ![]() |
MTS™ Imipenem-relebactam | rev.1.1 - 31/07/2020 | ![]() |
MTS™ Doxycycline | rev.0 - 23/08/2019 | ![]() |
MTS™ Gentamicin | rev.0 - 03/07/2019 | ![]() |
MTS™ Ciprofloxacin | rev.1 - 30/08/2019 | ![]() |
MTS™ Levofloxacin | rev.1 - 30/08/2019 | ![]() |
MTS™ Tetracycline | rev.0.1 - 01/09/2020 | ![]() |
MTS™ Omadacycline | rev.1 - 20/03/2020 | ![]() ![]() |
MTS™ Eravacycline | rev.0 - 02/11/2018 | ![]() |
MTS™ Penicillin G | rev.0.1 - 31/01/2020 | ![]() |
MTS™ Plazomicin | rev.0 - 31/07/2018 | ![]() |
MTS™ Delafloxacin | rev.1 - 29/06/2018 | ![]() ![]() |
MTS™ Azithromycin | rev.0 - 29/05/2018 | ![]() |
MTS™ Meropenem | rev.2 - 18/05/2020 | ![]() |
MTS™ Tedizolid | rev.2 - 23/10/2017 | ![]() ![]() |
MTS™ Erythromycin | rev.0.1 - 31/01/2020 | ![]() |
MTS™ Clindamycin | rev.0.1 - 14/07/2020 | ![]() |
MTS™ Meropenem-vaborbactam | rev.1.1 - 15/12/2020 | ![]() |
MTS™ Ceftazidime-avibactam | rev.0.1 - 30/03/2020 | ![]() |
MTS™ Linezolid | rev.0.1 - 11/05/2018 | ![]() |
MTS™ Telavancin | rev.1 - 30/08/2017 | ![]() |
MTS™ Ceftazidime | rev.1 - 20/01/2021 | ![]() |
MTS™ Ceftolozane-tazobactam | rev.3 - 23/04/2020 | ![]() |
MTS™ Dalbavancin | rev.1 - 20/01/2017 | ![]() |
MTS™ Vancomycin | rev.2 - 15/11/2019 | ![]() |