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Data / Medical devices / Powered Microneedle Device / United States

FDA-registered makers of Powered Microneedle Device in the United States: 17 establishments

17 establishments in the United States are registered with the FDA to make Powered Microneedle Device (product code QAI). 10 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Powered Microneedle Device
Product code
QAI
Country
United States

Makers of Powered Microneedle Device in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Bellus Medical, LLCJohnson City, TN, United StatesComplaint file establishment, Specification developer3August 29, 2024010api.fda.gov
HydraFacial LLCLong Beach, CA, United StatesSpecification developer3February 19, 2026000api.fda.gov
Su-Ko Technologies LLCAustin, TX, United StatesComplaint file establishment, Specification developer2October 29, 2025000api.fda.gov
Cytrellis Biosystems, Inc.Woburn, MA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1July 9, 2021020api.fda.gov
Dermalogica, LLCCarson, CA, United StatesComplaint file establishment, Specification developer1August 25, 2025000api.fda.gov
DermaqualJohnson City, TN, United StatesRepackager or relabeler, Specification developer1August 11, 2023000api.fda.gov
Equipmed Usa LLCNewport Beach, CA, United StatesManufacturer1December 20, 2022000api.fda.gov
Induction Therapies, LLCLouisville, KY, United StatesSpecification developer1October 21, 2022000api.fda.gov
Refine Usa, LLCJacksonville Beach, FL, United StatesSpecification developer1April 9, 2020000api.fda.gov
Venus Concept Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer1December 20, 2022000api.fda.gov
ARCH Medical & Aerospace - WoburnWoburn, MA, United StatesContract manufacturer0000api.fda.gov
Cirtronics CorporationMilford, NH, United StatesContract manufacturer0000api.fda.gov
CogmedixWest Boylston, MA, United StatesContract manufacturer0000api.fda.gov
Global Interconnect, Inc.Pocasset, MA, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - Mansfield, BridgemedicaMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesContract manufacturer0000api.fda.gov
Trident Manufacturing, Inc.Pingree Grove, IL, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. 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.