Data / Medical devices / Orthosis, Cranial, Laser Scan / United States
FDA-registered makers of Orthosis, Cranial, Laser Scan in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Orthosis, Cranial, Laser Scan (product code OAN). 4 have a 510(k) clearance or PMA approval on file and 0 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
- Orthosis, Cranial, Laser Scan
- Product code
- OAN
- Country
- United States
Makers of Orthosis, Cranial, Laser Scan in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Orthomerica Products, Inc. | Orlando, FL, United States | Manufacturer, Specification developer | 16 | March 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cranial Technologies, Inc. | Chandler, AZ, United States | Manufacturer | 2 | March 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Biosculptor Corporation | Hialeah, FL, United States | Manufacturer | 1 | January 27, 2009 | 0 | 0 | 0 | api.fda.gov |
| Symbiont Logistics, LLC | Phoenix, AZ, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | January 9, 2008 | 0 | 0 | 0 | api.fda.gov |
| Abcorp | Boston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abcorp 3D | Columbia, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Danmar Products, Inc. | Ann Arbor, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invent Medical Usa, LLC | Loveland, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invent Medical Usa, LLC | Warminster, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Otto Bock Healthcare LP | Salt Lake City, UT, United States | 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.