Data / Medical devices / United States / Falck Medical Corporation
Falck Medical Corporation: FDA-registered device maker in Mystic, CT, United States, 1 510(k) clearance
Falck Medical Corporation is registered with the FDA (registration 1226586) in Mystic, CT, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 3, 2008. 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
- 1226586
- FEI number
- 3003156974
- Address
- 35 Washington ST. Suite 200, Mystic, CT, United States, 06355
- Owner or operator
- FALCK MEDICAL CORPORATION (9042463)
- Roles
- Manufacturer
- First device listed
- June 1, 2008
- Registered through
- 2026
- Brand names listed
- FAT2 , FAT1, Falck Medical Multifunction Devices
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tonograph | HPK | 2 | Manufacturer | accessdata.fda.gov |
| Tonometer, Analyzer, Ocular Blood Flow | NJJ | 2 | Manufacturer | accessdata.fda.gov |
| Tonometer, Manual | HKY | 2 | 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 |
|---|---|---|---|---|---|---|
| June 3, 2008 | K071755 | FALCK APPLANATION TONOMETER (FAT2) | HKY | Substantially Equivalent | Falck Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 3, 2008. 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.