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.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Powered Microneedle Device
- Product code
- QAI
- Country
- United States
Makers of Powered Microneedle Device in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bellus Medical, LLC | Johnson City, TN, United States | Complaint file establishment, Specification developer | 3 | August 29, 2024 | 0 | 1 | 0 | api.fda.gov |
| HydraFacial LLC | Long Beach, CA, United States | Specification developer | 3 | February 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Su-Ko Technologies LLC | Austin, TX, United States | Complaint file establishment, Specification developer | 2 | October 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cytrellis Biosystems, Inc. | Woburn, MA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | July 9, 2021 | 0 | 2 | 0 | api.fda.gov |
| Dermalogica, LLC | Carson, CA, United States | Complaint file establishment, Specification developer | 1 | August 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Dermaqual | Johnson City, TN, United States | Repackager or relabeler, Specification developer | 1 | August 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Equipmed Usa LLC | Newport Beach, CA, United States | Manufacturer | 1 | December 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Induction Therapies, LLC | Louisville, KY, United States | Specification developer | 1 | October 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Refine Usa, LLC | Jacksonville Beach, FL, United States | Specification developer | 1 | April 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Venus Concept Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer | 1 | December 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| ARCH Medical & Aerospace - Woburn | Woburn, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtronics Corporation | Milford, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogmedix | West Boylston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Interconnect, Inc. | Pocasset, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Mansfield, Bridgemedica | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tidi Products, LLC | Neenah, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trident Manufacturing, Inc. | Pingree Grove, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.