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Data / FDA device clearances / Virginia

FDA device clearances in Virginia: 40 since Nov 2024

The full list. FDA device clearances for applicants in Virginia: 40 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 1 row 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/virginia, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 20, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 40 device decisions for applicants in Virginia from November 13, 2024 to October 20, 2026: 30 510(k) clearances and De Novo grants and 10 PMA approvals and supplements, for 21 applicants. The newest, K262093 on October 20, 2026, is Accuro XV from Rivanna Medical, Inc..

The request: Every new FDA device clearance or approval for a company in Virginia, 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.

  • 40Decisions
  • 30510(k) and De Novo
  • 10PMA
  • October 20, 2026Latest decision

Newest decisions

The newest 40 of 40, 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 20, 2026K262093Accuro XVRivanna Medical, Inc.VirginiaSubstantially Equivalent510(k) traditionalIYOaccessdata.fda.gov
September 3, 2026P170012/S032HEMOBLAST™ BellowsDilon Technologies, Inc.VirginiaApprovedPMA 180-day supplementPMXaccessdata.fda.gov
August 10, 2026K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.VirginiaSubstantially Equivalent510(k) traditionalITXaccessdata.fda.gov
July 24, 2026K261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.VirginiaSubstantially Equivalent510(k) traditionalITXaccessdata.fda.gov
July 24, 2026K253452Accuro 3SRivanna Medical, Inc.VirginiaSubstantially Equivalent510(k) traditionalIYOaccessdata.fda.gov
June 27, 2026K261122MIST ICImagine Milling Technologies, LLCVirginiaSubstantially Equivalent510(k) traditionalNHAaccessdata.fda.gov
June 18, 2026K254169SmartSpectra Vital Signs Monitor 1.0Presage Security, Inc. d/b/a Presage Technologies, Inc.VirginiaSubstantially Equivalent510(k) traditionalQMEaccessdata.fda.gov
May 13, 2026P190030/S004ActaStim-STheragen, Inc.VirginiaApprovedPMA 180-day supplementLOFaccessdata.fda.gov
April 28, 2026P170012/S031HEMOBLAST® BellowsDilon Technologies, Inc.VirginiaApprovedPMA 180-day supplementPMXaccessdata.fda.gov
April 20, 2026K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoahVirginiaSubstantially Equivalent510(k) traditionalLZHaccessdata.fda.gov
April 9, 2026K254021Accuro XVRivanna Medical, Inc.VirginiaSubstantially Equivalent510(k) traditionalIYOaccessdata.fda.gov
April 2, 2026P040029/S026Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon...Euclid Vision CorporationVirginia30-day notice acceptedPMA 30-day noticeNUUaccessdata.fda.gov
March 17, 2026K260546Q Pedicle InstrumentsK2m, Inc.VirginiaSubstantially Equivalent510(k) specialOLOaccessdata.fda.gov
March 12, 2026P040029/S025Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon...Euclid Vision CorporationVirginiaApprovedPMA 180-day supplementNUUaccessdata.fda.gov
March 6, 2026P040029/S021Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A)...Euclid Vision CorporationVirginiaApprovedPMA 180-day supplementNUUaccessdata.fda.gov
February 17, 2026K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.VirginiaSubstantially Equivalent510(k) specialQEYaccessdata.fda.gov
February 10, 2026K253545Vulcan Spinal SystemK2m, Inc.VirginiaSubstantially Equivalent510(k) traditionalNKBaccessdata.fda.gov
February 6, 2026K252873Q Interbody InstrumentsK2m, Inc.VirginiaSubstantially Equivalent510(k) traditionalOLOaccessdata.fda.gov
December 19, 2025K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.VirginiaSubstantially Equivalent510(k) traditionalCAFaccessdata.fda.gov
September 26, 2025K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalVirginiaSubstantially Equivalent510(k) traditionalDXGaccessdata.fda.gov
September 19, 2025K252647Tapestry Biointegrative ImplantEmbody, Inc.VirginiaSubstantially Equivalent510(k) specialOWYaccessdata.fda.gov
September 9, 2025K251682MuscleView 2.0Springbok, Inc. (Dba Springbok Analytics)VirginiaSubstantially Equivalent510(k) traditionalLNHaccessdata.fda.gov
July 9, 2025K243731HEXIM Implant; Samwon General AbutmentsP&a USAVirginiaSubstantially Equivalent510(k) traditionalDZEaccessdata.fda.gov
June 24, 2025K243009MIST ICImagine Milling Technologies, LLCVirginiaSubstantially Equivalent510(k) traditionalNHAaccessdata.fda.gov
June 20, 2025K243589PAL Sterilization CaseMicroaire Surgical Instruments, LLCVirginiaSubstantially Equivalent510(k) traditionalKCTaccessdata.fda.gov
June 18, 2025K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam...O&M Halyard, Inc.VirginiaSubstantially Equivalent510(k) abbreviatedLZAaccessdata.fda.gov
June 13, 2025K250469Accuro® 3S Needle Guide KitRivanna Medical, Inc.VirginiaSubstantially Equivalent510(k) traditionalITXaccessdata.fda.gov
May 30, 2025K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical...Owens & Minor (O&M) Halyard, Inc.VirginiaSubstantially Equivalent510(k) abbreviatedFXXaccessdata.fda.gov
May 23, 2025P040029/S023Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon...Euclid Vision CorporationVirginiaApprovedPMA 180-day supplementNUUaccessdata.fda.gov
May 23, 2025K243937Accuro 3SRivanna Medical, Inc.VirginiaSubstantially Equivalent510(k) traditionalIYOaccessdata.fda.gov
April 25, 2025K244026PAL 7020 ConsoleMicroaire Surgical Instruments, LLCVirginiaSubstantially Equivalent510(k) traditionalQPBaccessdata.fda.gov
April 2, 2025K242460Progenix Select StimProgenix, LLCVirginiaSubstantially Equivalent510(k) traditionalNUHaccessdata.fda.gov
March 31, 2025P170012/S030HEMOBLAST™ BellowsDilon Technologies, Inc.Virginia30-day notice acceptedPMA 30-day noticePMXaccessdata.fda.gov
February 10, 2025K243063Myolight Microcurrent HandpieceRaja Trading Company, Inc.VirginiaSubstantially Equivalent510(k) traditionalNFOaccessdata.fda.gov
December 30, 2024K242804PAL Aspiration SystemMicroaire Surgical Instruments, LLCVirginiaSubstantially Equivalent510(k) traditionalQPBaccessdata.fda.gov
December 23, 2024P040029/S024Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A)...Euclid Vision CorporationVirginia30-day notice acceptedPMA 30-day noticeNUUaccessdata.fda.gov
December 17, 2024K242558Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy...O&M Halyard, Inc.VirginiaSubstantially Equivalent510(k) abbreviatedLZAaccessdata.fda.gov
November 25, 2024K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.VirginiaSubstantially Equivalent510(k) traditionalQEYaccessdata.fda.gov
November 21, 2024K242799PliaFX FloLifenet HealthVirginiaSubstantially Equivalent510(k) traditionalMBPaccessdata.fda.gov
November 13, 2024P190030/S003ActaStim-S Spine Fusion StimulatorTheragen, Inc.VirginiaApprovedPMA real-time process supplementLOFaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Rivanna Medical, Inc.6October 20, 2026
Euclid Vision Corporation5April 2, 2026
Dilon Technologies, Inc.3September 3, 2026
K2m, Inc.3March 17, 2026
Microaire Surgical Instruments, LLC3June 20, 2025
Imagine Milling Technologies, LLC2June 27, 2026
Theragen, Inc.2May 13, 2026
Liquet Medical, Inc.2February 17, 2026
O&M Halyard, Inc.2June 18, 2025
EM-TECH Solutions, Inc.1August 10, 2026
Presage Security, Inc. d/b/a Presage Technologies, Inc.1June 18, 2026
Luminoah1April 20, 2026
Pari Respiratory Equipment, Inc.1December 19, 2025
Caretaker Medical1September 26, 2025
Embody, Inc.1September 19, 2025
Springbok, Inc. (Dba Springbok Analytics)1September 9, 2025
P&a USA1July 9, 2025
Owens & Minor (O&M) Halyard, Inc.1May 30, 2025
Progenix, LLC1April 2, 2025
Raja Trading Company, Inc.1February 10, 2025

By panel

PanelDecisionsLatest
Radiology8October 20, 2026
General, Plastic Surgery7September 3, 2026
Ophthalmic5April 2, 2026
Cardiovascular4June 18, 2026
Orthopedic4May 13, 2026
General Hospital4April 20, 2026
Neurology4March 17, 2026
Dental3June 27, 2026
Anesthesiology1December 19, 2025

By decision type

Decision typeDecisionsLatest
510(k) traditional24October 20, 2026
PMA 180-day supplement6September 3, 2026
PMA 30-day notice3April 2, 2026
510(k) special3March 17, 2026
510(k) abbreviated3June 18, 2025
PMA real-time process supplement1November 13, 2024

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.