Data / FDA device clearances / Missouri
FDA device clearances in Missouri: 43 since Nov 2024
The full list. FDA device clearances for applicants in Missouri: 43 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 3 rows a month. The new rows come each week by email, $19 a month.
Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery.
For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/state/missouri, and every list with its row count and price is at https://specstream.ai/data/lists.json.
Updated October 16, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).
FDA made 43 device decisions for applicants in Missouri from November 19, 2024 to October 16, 2026: 28 510(k) clearances and De Novo grants and 15 PMA approvals and supplements, for 22 applicants. The newest, K261245 on October 16, 2026, is Restrata from Acera Surgical, Inc..
The request: Every new FDA device clearance or approval for a company in Missouri, with its address, the device and the product code. $10 of credit on sign-up, no card.
SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.
- 43Decisions
- 28510(k) and De Novo
- 15PMA
- October 16, 2026Latest decision
Newest decisions
The newest 43 of 43, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.
| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
|---|---|---|---|---|---|---|---|---|
| October 16, 2026 | K261245 | Restrata | Acera Surgical, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | QSZ | accessdata.fda.gov |
| October 2, 2026 | P230019/S005 | MediBeacon Transdermal GFR System | Medibeacon, Inc. | Missouri | Approved | PMA special supplement | SDK | accessdata.fda.gov |
| October 1, 2026 | K260283 | VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) | bioMerieux, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | LON | accessdata.fda.gov |
| September 28, 2026 | K260619 | VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) | Biomérieux, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | LON | accessdata.fda.gov |
| September 8, 2026 | P230001/S014 | ColoSense® | Geneoscopy, Inc. | Missouri | Approved | PMA real-time process supplement | SBB | accessdata.fda.gov |
| August 27, 2026 | P230001/S012 | ColoSense® | Geneoscopy, Inc. | Missouri | Approved | PMA 180-day supplement | SBB | accessdata.fda.gov |
| August 27, 2026 | K262744 | GenesisX RMN | Stereotaxis, Inc. | Missouri | Substantially Equivalent | 510(k) special | DXX | accessdata.fda.gov |
| August 19, 2026 | K253240 | PrecivityAD2 Test | C2N Diagnostics, LLC | Missouri | Substantially Equivalent | 510(k) traditional | SET | accessdata.fda.gov |
| July 31, 2026 | P240014/S001 | MAGiC Ablation Catheter | Stereotaxis, Inc. | Missouri | Approved | PMA 180-day supplement | LPB | accessdata.fda.gov |
| July 27, 2026 | K250419 | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature... | Plus EV Holdings, Inc. D/B/A Intimate Rose | Missouri | Substantially Equivalent | 510(k) traditional | OSD | accessdata.fda.gov |
| July 8, 2026 | K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | SAN | accessdata.fda.gov |
| June 10, 2026 | P230019/S002 | MediBeacon® Transdermal GFR Measurement System (TGFR) | Medibeacon, Inc. | Missouri | Approved | PMA real-time process supplement | SDK | accessdata.fda.gov |
| May 15, 2026 | K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite... | Bausch and Lomb | Missouri | Substantially Equivalent | 510(k) special | HQC | accessdata.fda.gov |
| April 15, 2026 | K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | LON | accessdata.fda.gov |
| April 1, 2026 | K253473 | Synchrony | Stereotaxis, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | DQK | accessdata.fda.gov |
| March 26, 2026 | K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | Biomerieux | Missouri | Substantially Equivalent | 510(k) traditional | LON | accessdata.fda.gov |
| March 25, 2026 | K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | Missouri | Substantially Equivalent | 510(k) traditional | HQC | accessdata.fda.gov |
| January 5, 2026 | P240014 | MAGiC Ablation Catheter | Stereotaxis, Inc. | Missouri | Approved | PMA original approval | LPB | accessdata.fda.gov |
| December 15, 2025 | P230019/S001 | MediBeacon® Transdermal GFR Measurement System (TGFR) | Medibeacon, Inc. | Missouri | Approved | PMA 180-day supplement | SDK | accessdata.fda.gov |
| December 5, 2025 | K250743 | Remvia NightGuard | Remvia | Missouri | Substantially Equivalent | 510(k) traditional | MQC | accessdata.fda.gov |
| November 20, 2025 | P230019/S003 | MediBeacon® Transdermal GFR Measurement System (GFR) | Medibeacon, Inc. | Missouri | Approved | PMA 180-day supplement | SDK | accessdata.fda.gov |
| November 20, 2025 | K251365 | OptumSI Implant System | Si Solutions, LLC | Missouri | Substantially Equivalent | 510(k) traditional | OUR | accessdata.fda.gov |
| November 6, 2025 | K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | Stereotaxis, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | DXX | accessdata.fda.gov |
| October 24, 2025 | P230001/S011 | ColoSense® | Geneoscopy, Inc. | Missouri | 30-day notice accepted | PMA 30-day notice | SBB | accessdata.fda.gov |
| October 20, 2025 | K242827 | A8 INTEGR8 Porous Pedicle Screws | Allumin8, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | NKB | accessdata.fda.gov |
| October 2, 2025 | K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | Missouri | Substantially Equivalent | 510(k) traditional | BYI | accessdata.fda.gov |
| September 15, 2025 | P230001/S009 | ColoSense® | Geneoscopy, Inc. | Missouri | Approved | PMA real-time process supplement | SBB | accessdata.fda.gov |
| August 21, 2025 | K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | LON | accessdata.fda.gov |
| August 18, 2025 | K251086 | PnueAira (PNCU-01) | Biotab, LLC | Missouri | Substantially Equivalent | 510(k) traditional | JOW | accessdata.fda.gov |
| August 15, 2025 | K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | Missouri | Substantially Equivalent | 510(k) special | GZJ | accessdata.fda.gov |
| August 14, 2025 | P230001/S010 | ColoSense® | Geneoscopy, Inc. | Missouri | 30-day notice accepted | PMA 30-day notice | SBB | accessdata.fda.gov |
| July 24, 2025 | K250322 | Respond OC Conserving Regulator (130-0800) | Responsive Respiratory | Missouri | Substantially Equivalent | 510(k) traditional | NFB | accessdata.fda.gov |
| July 23, 2025 | K250590 | MAGiC Sweep EP Mapping Catheter | Stereotaxis, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | DRF | accessdata.fda.gov |
| July 3, 2025 | P230001/S008 | ColoSense® | Geneoscopy, Inc. | Missouri | Approved | PMA 180-day supplement | SBB | accessdata.fda.gov |
| June 20, 2025 | K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | OXF | accessdata.fda.gov |
| May 14, 2025 | P230001/S005 | ColoSense | Geneoscopy, Inc. | Missouri | Approved | PMA 180-day supplement | SBB | accessdata.fda.gov |
| May 2, 2025 | K243457 | Nixall Antimicrobial Solutions Skin & Wound Hydrogel | Seriously Clean, Ltd. | Missouri | Substantially Equivalent | 510(k) traditional | FRO | accessdata.fda.gov |
| March 28, 2025 | K243520 | Bullsai Confirm | Turing Medical Technologies, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | QQC | accessdata.fda.gov |
| March 14, 2025 | K234012 | VITEK COMPACT PRO | bioMerieux, Inc. | Missouri | Substantially Equivalent | 510(k) traditional | LON | accessdata.fda.gov |
| February 28, 2025 | K241041 | Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC | Missouri | Substantially Equivalent | 510(k) traditional | PHR | accessdata.fda.gov |
| January 17, 2025 | P230019 | MediBeacon® Transdermal GFR Measurement System (TGFR) | Medibeacon, Inc. | Missouri | Approved | PMA original approval | SDK | accessdata.fda.gov |
| December 19, 2024 | P230001/S007 | ColoSense | Geneoscopy, Inc. | Missouri | 30-day notice accepted | PMA 30-day notice | SBB | accessdata.fda.gov |
| November 19, 2024 | K242102 | CerroZone Mini | Cerrozone, LLC | Missouri | Substantially Equivalent | 510(k) traditional | FRF | accessdata.fda.gov |
Applicants with the most decisions
| Applicant | Decisions | Latest |
|---|---|---|
| Geneoscopy, Inc. | 8 | September 8, 2026 |
| Stereotaxis, Inc. | 6 | August 27, 2026 |
| Medibeacon, Inc. | 5 | October 2, 2026 |
| bioMerieux, Inc. | 5 | October 1, 2026 |
| Acera Surgical, Inc. | 2 | October 16, 2026 |
| Biomérieux, Inc. | 1 | September 28, 2026 |
| C2N Diagnostics, LLC | 1 | August 19, 2026 |
| Plus EV Holdings, Inc. D/B/A Intimate Rose | 1 | July 27, 2026 |
| Bausch and Lomb | 1 | May 15, 2026 |
| Biomerieux | 1 | March 26, 2026 |
| Bausch and Lomb, Incorporated | 1 | March 25, 2026 |
| Remvia | 1 | December 5, 2025 |
| Si Solutions, LLC | 1 | November 20, 2025 |
| Allumin8, Inc. | 1 | October 20, 2025 |
| Exemplar Medical, LLC | 1 | October 2, 2025 |
| Biotab, LLC | 1 | August 18, 2025 |
| N & C Holdings, LLC | 1 | August 15, 2025 |
| Responsive Respiratory | 1 | July 24, 2025 |
| Seriously Clean, Ltd. | 1 | May 2, 2025 |
| Turing Medical Technologies, Inc. | 1 | March 28, 2025 |
By panel
| Panel | Decisions | Latest |
|---|---|---|
| Pathology | 8 | September 8, 2026 |
| Microbiology | 7 | October 1, 2026 |
| Cardiovascular | 7 | August 27, 2026 |
| Gastroenterology, Urology | 5 | October 2, 2026 |
| Unknown | 3 | October 16, 2026 |
| Ophthalmic | 2 | May 15, 2026 |
| Orthopedic | 2 | November 20, 2025 |
| Anesthesiology | 2 | October 2, 2025 |
| Neurology | 2 | August 15, 2025 |
| Immunology | 1 | August 19, 2026 |
| Physical Medicine | 1 | July 27, 2026 |
| General, Plastic Surgery | 1 | June 20, 2025 |
| Dental | 1 | February 28, 2025 |
| General Hospital | 1 | November 19, 2024 |
By decision type
| Decision type | Decisions | Latest |
|---|---|---|
| 510(k) traditional | 25 | October 16, 2026 |
| PMA 180-day supplement | 6 | August 27, 2026 |
| PMA real-time process supplement | 3 | September 8, 2026 |
| 510(k) special | 3 | August 27, 2026 |
| PMA 30-day notice | 3 | October 24, 2025 |
| PMA original approval | 2 | January 5, 2026 |
| PMA special supplement | 1 | October 2, 2026 |
Where FDA publishes these decisions
CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.