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FDA 510(k) & PMA Approved Dispositivos — 35 products

Total de dispositivos35
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K260696 MTS Gepotidacin 0.016-256 µg/mLJWY2026-04-17 Ver
510(k) K252114 MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLJWY2025-10-02 Ver
510(k) K251580 MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)JWY2025-08-20 Ver
510(k) K243202 MTS Ceftobiprole 0.002-32 µg/mLJWY2025-01-30 Ver
510(k) K230479 ComASP Cefiderocol 0.008-128JWY2023-05-18 Ver
510(k) K211672 MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mLJWY2021-10-20 Ver
510(k) K200180 MTS Omadacycline 0.002 - 32 ug/mLJWY2020-03-20 Ver
510(k) K192345 MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mLJWY2019-10-31 Ver
510(k) K191908 MTS Imipenem 0.016-256 µg/mLJWY2019-09-04 Ver
510(k) K191809 MTS Imipenem-relebactam 0.002/4-32/4 µg/mLJWY2019-08-23 Ver
510(k) K190914 MTS Doxycycline 0.016 - 256 µg/mLJWY2019-05-29 Ver
510(k) K190252 MTS Gentamicin 0.016 - 256 µg/mLJWY2019-03-22 Ver
510(k) K183527 MTS Ciprofloxacin 0.002 - 32 µg/mLJWY2019-03-19 Ver
510(k) K183140 MTS Tetracycline 0.016 - 256 ug/mLJWY2019-01-11 Ver
510(k) K183115 MTS Levofloxacin 0.002 - 32 µg/mLJWY2018-12-20 Ver
510(k) K182922 MTS Omadacycline 0.002-32 µg/mLJWY2018-12-14 Ver
510(k) K182557 MTS Eravacycline 0.002 - 32 µg/mLJWY2018-11-02 Ver
510(k) K181889 MTS Penicillin 0.002- 32 µg/mLJWY2018-09-13 Ver
510(k) K181708 MTS Plazomicin 0.016-256 µg/mLJWY2018-07-31 Ver
510(k) K180886 Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mLJWY2018-05-18 Ver
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