15 premarket notifications (510(k)s) from applicants based in Missouri were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.
| Decided | Applicant | Device | Area | Where | Record |
|---|---|---|---|---|---|
| 2026-10-01 | bioMerieux, Inc. | VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) LON | Microbiology | Hazelwood, Missouri | K260283 |
| 2026-09-28 | Biomérieux, Inc. | VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) LON | Microbiology | Hazelwood, Missouri | K260619 |
| 2026-08-27 | Stereotaxis, Inc. | GenesisX RMN DXX | Cardiovascular | St. Louis, Missouri | K262744 |
| 2026-08-19 | C2N Diagnostics, LLC | PrecivityAD2 Test SET | Immunology | St. Louis, Missouri | K253240 |
| 2026-07-27 | Plus EV Holdings, Inc. D/B/A Intimate Rose | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) OSD | Physical Medicine | North Kansas City, Missouri | K250419 |
| 2026-07-08 | bioMerieux, Inc. | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System SAN | Microbiology | Hazelwood, Missouri | K260160 |
| 2026-05-15 | Bausch and Lomb | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+ HQC | Ophthalmic | Saint Louis, Missouri | K261264 |
| 2026-04-15 | bioMerieux, Inc. | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance LON | Microbiology | Hazelwood, Missouri | K260282 |
| 2026-04-01 | Stereotaxis, Inc. | Synchrony DQK | Cardiovascular | Saint Louis, Missouri | K253473 |
| 2026-03-26 | BIOMERIEUX | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) LON | Microbiology | Hazelwood, Missouri | K260281 |
| 2026-03-25 | Bausch and Lomb, Incorporated | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) HQC | Ophthalmic | St. Louis, Missouri | K252052 |
| 2025-12-05 | Remvia | Remvia NightGuard MQC | Unknown | St. Louis, Missouri | K250743 |
| 2025-11-20 | Si Solutions, LLC | OptumSI Implant System OUR | Orthopedic | Columbia, Missouri | K251365 |
| 2025-11-06 | Stereotaxis, Inc. | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) DXX | Cardiovascular | Saint Louis, Missouri | K251792 |
| 2025-10-20 | Allumin8, Inc. | A8 INTEGR8 Porous Pedicle Screws NKB | Orthopedic | Springfield, Missouri | K242827 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
Cite this page
https://mentionfox.com/fda/510k/state/mo