Posted: 6/10/2019
Posted; 6/10/2019
6/10/2019 | BK190351 - ALYX Component Collection System |
6/10/2019 | BK190324 - VISTASEAL Laparoscopic Dual Applicator (35 cm Rigid or 45 cm Flexible) |
6/7/2019 | June 7, 2019 Approval Letter - RAGWITEK |
6/3/2019 | Complete List of Currently Approved NDA and ANDA Application Submissions Updated as of 5/31/2019 |
6/3/2019 | Complete List of Currently Approved Premarket Applications (PMAs) Updated as of 5/31/2019 |
6/3/2019 | Complete List of Substantially Equivalent 510(k) Device Applications Updated as of 5/31/2019 |
6/3/2019 | Complete List of Licensed Products and Establishments Updated as of 5/31/2019 |
5/30/2019 | May 28, 2019 Untitled Letter - R3 Stem Cell, LLC |
5/30/2019 | Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans Update as of 5/30/2019 |
5/30/2019 | Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 Updated as of 5/30/2019 |
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