Data / Medical devices / Orthosis, Cranial, Laser Scan
Orthosis, Cranial, Laser Scan (OAN): 11 FDA-registered makers in 2 countries
11 establishments in 2 countries are registered with the FDA to make Orthosis, Cranial, Laser Scan (product code OAN, Class 2, 21 CFR 882.5970). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on March 17, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OAN
- Device class
- 2
- Regulation
- 882.5970
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Canada | 1 |
Makers of Orthosis, Cranial, Laser Scan
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 | |
| Vorum Research Corporation | Vancouver British Columbia, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 17, 2025. 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.