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Data / FDA device clearances / New Hampshire

FDA device clearances in New Hampshire: 21 since Nov 2024

The full list. FDA device clearances for applicants in New Hampshire: 21 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/new-hampshire, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 15, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 21 device decisions for applicants in New Hampshire from November 27, 2024 to October 15, 2026: 15 510(k) clearances and De Novo grants and 6 PMA approvals and supplements, for 10 applicants. The newest, K262576 on October 15, 2026, is twiist Loop Algorithm from Deka Research and Development Corp..

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

  • 21Decisions
  • 15510(k) and De Novo
  • 6PMA
  • October 15, 2026Latest decision

Newest decisions

The newest 21 of 21, 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 15, 2026K262576twiist Loop AlgorithmDeka Research and Development Corp.New HampshireSubstantially Equivalent510(k) traditionalQJIaccessdata.fda.gov
October 2, 2026K260064NeuroraArgus Cognitive, Inc.New HampshireSubstantially Equivalent510(k) traditionalQPFaccessdata.fda.gov
September 9, 2026K251417ReVISION 2Argus Cognitive, Inc.New HampshireSubstantially Equivalent510(k) traditionalQIHaccessdata.fda.gov
July 24, 2026K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpNew HampshireSubstantially Equivalent510(k) traditionalFRNaccessdata.fda.gov
June 17, 2026K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and DevelopmentNew HampshireSubstantially Equivalent510(k) specialQFGaccessdata.fda.gov
June 3, 2026K261530iiSure Infusion SetDeka Research and DevelopmentNew HampshireSubstantially Equivalent510(k) specialFPAaccessdata.fda.gov
May 13, 2026P120003/S007iCast Covered Stent SystemAtrium Medical Corp.New HampshireApprovedPMA 135-day supplementPRLaccessdata.fda.gov
April 13, 2026K254078HVT 2.0Vapotherm, Inc.New HampshireSubstantially Equivalent510(k) traditionalBTTaccessdata.fda.gov
January 15, 2026K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet CorporationNew HampshireSubstantially Equivalent510(k) traditionalBZDaccessdata.fda.gov
December 22, 2025P120003/S009iCast Covered Stent SystemAtrium Medical Corp.New HampshireApprovedPMA 180-day supplementPRLaccessdata.fda.gov
October 10, 2025K243815SoClean 3+Soclean, Inc.New HampshireSubstantially Equivalent510(k) traditionalQXQaccessdata.fda.gov
September 12, 2025P120003/S011iCast Covered Stent SystemAtrium Medical Corp.New Hampshire30-day notice acceptedPMA 30-day noticePRLaccessdata.fda.gov
August 20, 2025P120003/S010iCast Covered Stent SystemAtrium Medical Corp.New Hampshire30-day notice acceptedPMA 30-day noticePRLaccessdata.fda.gov
August 1, 2025K243841Sparta Infusion Set for InsulinDeka Research and DevelopmentNew HampshireSubstantially Equivalent510(k) traditionalFPAaccessdata.fda.gov
July 7, 2025P120003/S006iCast Covered Stent SystemAtrium Medical Corp.New HampshireApprovedPMA 180-day supplementPRLaccessdata.fda.gov
May 1, 2025P120003/S008iCast Covered Stent SystemAtrium Medical Corp.New Hampshire30-day notice acceptedPMA 30-day noticePRLaccessdata.fda.gov
April 2, 2025K250930twiist systemDeka Research & Development Corp.New HampshireSubstantially Equivalent510(k) specialQFGaccessdata.fda.gov
March 11, 2025K250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionDeka Research & Development Corp.New HampshireSubstantially Equivalent510(k) specialFRNaccessdata.fda.gov
January 30, 2025K243442iBOT® PMDMobius MobilityNew HampshireSubstantially Equivalent510(k) traditionalIMKaccessdata.fda.gov
January 16, 2025K241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp.New HampshireSubstantially Equivalent510(k) traditionalFRNaccessdata.fda.gov
November 27, 2024K243354Remunity SystemDeka Research & Development Corp.New HampshireSubstantially Equivalent510(k) specialQJYaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Atrium Medical Corp.6May 13, 2026
Deka Research and Development3June 17, 2026
Deka Research & Development Corp.3April 2, 2025
Deka Research and Development Corp.2October 15, 2026
Argus Cognitive, Inc.2October 2, 2026
Deka R&D Corp1July 24, 2026
Vapotherm, Inc.1April 13, 2026
Sleepnet Corporation1January 15, 2026
Soclean, Inc.1October 10, 2025
Mobius Mobility1January 30, 2025

By panel

PanelDecisionsLatest
General Hospital7July 24, 2026
Cardiovascular6May 13, 2026
Clinical Chemistry3October 15, 2026
Anesthesiology2April 13, 2026
Neurology1October 2, 2026
Radiology1September 9, 2026
Physical Medicine1January 30, 2025

By decision type

Decision typeDecisionsLatest
510(k) traditional10October 15, 2026
510(k) special5June 17, 2026
PMA 30-day notice3September 12, 2025
PMA 180-day supplement2December 22, 2025
PMA 135-day supplement1May 13, 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.