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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 dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 16, 2026K261245RestrataAcera Surgical, Inc.MissouriSubstantially Equivalent510(k) traditionalQSZaccessdata.fda.gov
October 2, 2026P230019/S005MediBeacon Transdermal GFR SystemMedibeacon, Inc.MissouriApprovedPMA special supplementSDKaccessdata.fda.gov
October 1, 2026K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)bioMerieux, Inc.MissouriSubstantially Equivalent510(k) traditionalLONaccessdata.fda.gov
September 28, 2026K260619VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)Biomérieux, Inc.MissouriSubstantially Equivalent510(k) traditionalLONaccessdata.fda.gov
September 8, 2026P230001/S014ColoSense®Geneoscopy, Inc.MissouriApprovedPMA real-time process supplementSBBaccessdata.fda.gov
August 27, 2026P230001/S012ColoSense®Geneoscopy, Inc.MissouriApprovedPMA 180-day supplementSBBaccessdata.fda.gov
August 27, 2026K262744GenesisX RMNStereotaxis, Inc.MissouriSubstantially Equivalent510(k) specialDXXaccessdata.fda.gov
August 19, 2026K253240PrecivityAD2 TestC2N Diagnostics, LLCMissouriSubstantially Equivalent510(k) traditionalSETaccessdata.fda.gov
July 31, 2026P240014/S001MAGiC Ablation CatheterStereotaxis, Inc.MissouriApprovedPMA 180-day supplementLPBaccessdata.fda.gov
July 27, 2026K250419Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature...Plus EV Holdings, Inc. D/B/A Intimate RoseMissouriSubstantially Equivalent510(k) traditionalOSDaccessdata.fda.gov
July 8, 2026K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc.MissouriSubstantially Equivalent510(k) traditionalSANaccessdata.fda.gov
June 10, 2026P230019/S002MediBeacon® Transdermal GFR Measurement System (TGFR)Medibeacon, Inc.MissouriApprovedPMA real-time process supplementSDKaccessdata.fda.gov
May 15, 2026K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™...Bausch and LombMissouriSubstantially Equivalent510(k) specialHQCaccessdata.fda.gov
April 15, 2026K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.MissouriSubstantially Equivalent510(k) traditionalLONaccessdata.fda.gov
April 1, 2026K253473SynchronyStereotaxis, Inc.MissouriSubstantially Equivalent510(k) traditionalDQKaccessdata.fda.gov
March 26, 2026K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BiomerieuxMissouriSubstantially Equivalent510(k) traditionalLONaccessdata.fda.gov
March 25, 2026K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedMissouriSubstantially Equivalent510(k) traditionalHQCaccessdata.fda.gov
January 5, 2026P240014MAGiC Ablation CatheterStereotaxis, Inc.MissouriApprovedPMA original approvalLPBaccessdata.fda.gov
December 15, 2025P230019/S001MediBeacon® Transdermal GFR Measurement System (TGFR)Medibeacon, Inc.MissouriApprovedPMA 180-day supplementSDKaccessdata.fda.gov
December 5, 2025K250743Remvia NightGuardRemviaMissouriSubstantially Equivalent510(k) traditionalMQCaccessdata.fda.gov
November 20, 2025P230019/S003MediBeacon® Transdermal GFR Measurement System (GFR)Medibeacon, Inc.MissouriApprovedPMA 180-day supplementSDKaccessdata.fda.gov
November 20, 2025K251365OptumSI Implant SystemSi Solutions, LLCMissouriSubstantially Equivalent510(k) traditionalOURaccessdata.fda.gov
November 6, 2025K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)Stereotaxis, Inc.MissouriSubstantially Equivalent510(k) traditionalDXXaccessdata.fda.gov
October 24, 2025P230001/S011ColoSense®Geneoscopy, Inc.Missouri30-day notice acceptedPMA 30-day noticeSBBaccessdata.fda.gov
October 20, 2025K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.MissouriSubstantially Equivalent510(k) traditionalNKBaccessdata.fda.gov
October 2, 2025K250860BreatheBand® (Model 1000)Exemplar Medical, LLCMissouriSubstantially Equivalent510(k) traditionalBYIaccessdata.fda.gov
September 15, 2025P230001/S009ColoSense®Geneoscopy, Inc.MissouriApprovedPMA real-time process supplementSBBaccessdata.fda.gov
August 21, 2025K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.MissouriSubstantially Equivalent510(k) traditionalLONaccessdata.fda.gov
August 18, 2025K251086PnueAira (PNCU-01)Biotab, LLCMissouriSubstantially Equivalent510(k) traditionalJOWaccessdata.fda.gov
August 15, 2025K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCMissouriSubstantially Equivalent510(k) specialGZJaccessdata.fda.gov
August 14, 2025P230001/S010ColoSense®Geneoscopy, Inc.Missouri30-day notice acceptedPMA 30-day noticeSBBaccessdata.fda.gov
July 24, 2025K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryMissouriSubstantially Equivalent510(k) traditionalNFBaccessdata.fda.gov
July 23, 2025K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.MissouriSubstantially Equivalent510(k) traditionalDRFaccessdata.fda.gov
July 3, 2025P230001/S008ColoSense®Geneoscopy, Inc.MissouriApprovedPMA 180-day supplementSBBaccessdata.fda.gov
June 20, 2025K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.MissouriSubstantially Equivalent510(k) traditionalOXFaccessdata.fda.gov
May 14, 2025P230001/S005ColoSenseGeneoscopy, Inc.MissouriApprovedPMA 180-day supplementSBBaccessdata.fda.gov
May 2, 2025K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd.MissouriSubstantially Equivalent510(k) traditionalFROaccessdata.fda.gov
March 28, 2025K243520Bullsai ConfirmTuring Medical Technologies, Inc.MissouriSubstantially Equivalent510(k) traditionalQQCaccessdata.fda.gov
March 14, 2025K234012VITEK COMPACT PRObioMerieux, Inc.MissouriSubstantially Equivalent510(k) traditionalLONaccessdata.fda.gov
February 28, 2025K241041Silver Fluoride Hypersensitivity VarnishYoung Dental Manufacturing Co. 1, LLCMissouriSubstantially Equivalent510(k) traditionalPHRaccessdata.fda.gov
January 17, 2025P230019MediBeacon® Transdermal GFR Measurement System (TGFR)Medibeacon, Inc.MissouriApprovedPMA original approvalSDKaccessdata.fda.gov
December 19, 2024P230001/S007ColoSenseGeneoscopy, Inc.Missouri30-day notice acceptedPMA 30-day noticeSBBaccessdata.fda.gov
November 19, 2024K242102CerroZone MiniCerrozone, LLCMissouriSubstantially Equivalent510(k) traditionalFRFaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Geneoscopy, Inc.8September 8, 2026
Stereotaxis, Inc.6August 27, 2026
Medibeacon, Inc.5October 2, 2026
bioMerieux, Inc.5October 1, 2026
Acera Surgical, Inc.2October 16, 2026
Biomérieux, Inc.1September 28, 2026
C2N Diagnostics, LLC1August 19, 2026
Plus EV Holdings, Inc. D/B/A Intimate Rose1July 27, 2026
Bausch and Lomb1May 15, 2026
Biomerieux1March 26, 2026
Bausch and Lomb, Incorporated1March 25, 2026
Remvia1December 5, 2025
Si Solutions, LLC1November 20, 2025
Allumin8, Inc.1October 20, 2025
Exemplar Medical, LLC1October 2, 2025
Biotab, LLC1August 18, 2025
N & C Holdings, LLC1August 15, 2025
Responsive Respiratory1July 24, 2025
Seriously Clean, Ltd.1May 2, 2025
Turing Medical Technologies, Inc.1March 28, 2025

By panel

PanelDecisionsLatest
Pathology8September 8, 2026
Microbiology7October 1, 2026
Cardiovascular7August 27, 2026
Gastroenterology, Urology5October 2, 2026
Unknown3October 16, 2026
Ophthalmic2May 15, 2026
Orthopedic2November 20, 2025
Anesthesiology2October 2, 2025
Neurology2August 15, 2025
Immunology1August 19, 2026
Physical Medicine1July 27, 2026
General, Plastic Surgery1June 20, 2025
Dental1February 28, 2025
General Hospital1November 19, 2024

By decision type

Decision typeDecisionsLatest
510(k) traditional25October 16, 2026
PMA 180-day supplement6August 27, 2026
PMA real-time process supplement3September 8, 2026
510(k) special3August 27, 2026
PMA 30-day notice3October 24, 2025
PMA original approval2January 5, 2026
PMA special supplement1October 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.