Data / Medical devices / United States / Danmar Products, Inc.
Danmar Products, Inc.: FDA-registered device maker in Ann Arbor, MI, United States, 3 510(k) clearances
Danmar Products, Inc. is registered with the FDA (registration 1831680) in Ann Arbor, MI, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 6, 2010. Registered through 2026. 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.
- FDA registration number
- 1831680
- Address
- 221 Jackson Industrial DR., Ann Arbor, MI, United States, 48103
- Owner or operator
- DANMAR PRODUCTS, INC. (1831680)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 27, 1992
- Registered through
- 2026
- Brand names listed
- CHEST SUPPORT, CRANIAL ADJUSTIVE PROSTHESIS, DANMAR PRODUCTS MICHIGAN CRANIAL HE, FlexCap, Orthosis, Cranial, Laser Scan, SIS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Helmet, Cranial, For Protective Use | NDA | 1 | Specification developer | accessdata.fda.gov |
| Orthosis, Cranial | MVA | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cranial, Laser Scan | OAN | 2 | Manufacturer | accessdata.fda.gov |
| Support, Head And Trunk, Wheelchair | IMS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 6, 2010 | K090341 | MICHIGAN CRANIAL RESHAPING ORTHOSIS | MVA | Substantially Equivalent | Danmar Products, Inc. | accessdata.fda.gov |
| October 31, 2003 | K013452 | DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS | MVA | Substantially Equivalent | Danmar Products, Inc. | accessdata.fda.gov |
| May 29, 2001 | K003630 | DANMAR PRODUCTS MICHIGAN CRANIAL HELMET | MVA | Substantially Equivalent | Danmar Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Support, Head And Trunk, Wheelchair
- All makers of Orthosis, Cranial, Laser Scan
- All makers of Orthosis, Cranial
- All makers of Helmet, Cranial, For Protective Use
Updated January 6, 2010. 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.