Data / Medical devices / United States / Alpha Medical Instruments LLC
Alpha Medical Instruments LLC: FDA-registered device maker in Mission Viejo, CA, United States, 1 510(k) clearance
Alpha Medical Instruments LLC is registered with the FDA (registration 3003289723) in Mission Viejo, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 20, 1998. 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
- 3003289723
- Address
- 23455 Madero Ste B, Mission Viejo, CA, United States, 92691
- Owner or operator
- ALPHA MEDICAL INSTRUMENTS INC (9034270)
- Roles
- Manufacturer
- First device listed
- January 30, 2013
- Registered through
- 2026
- Brand names listed
- Electrophysiology Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 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 |
|---|---|---|---|---|---|---|
| April 20, 1998 | K973639 | ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. | DRF | Substantially Equivalent | J-Lloyd Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 20, 1998. 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.