Data / Medical devices / United States / Ambi, Inc.
Ambi, Inc.: FDA-registered device maker in Capitola, CA, United States, 2 510(k) clearances
Ambi, Inc. is registered with the FDA (registration 3008061617) in Capitola, CA, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 28, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008061617
- Address
- 908 Sir Francis Ave., Capitola, CA, United States, 95010
- Owner or operator
- Ambi Inc. (10030464)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 6, 2009
- Registered through
- 2026
- Brand names listed
- Ambi-Lancet, Cold Pouch, Inject-Ease, Insul-Caps, Insul-eze, auto-Lancet
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Insulin Vial Protector/Holder | OJL | 1 | Manufacturer | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Manufacturer | accessdata.fda.gov |
| LDQ | LDQ | Specification developer | accessdata.fda.gov | |
| Magnifier, Hand-Held, Low-Vision | HJF | 1 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 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 28, 1995 | K942810 | PALCO LABS COLD POUCH | LDQ | Substantially Equivalent | Palco Laboratories, Inc. | accessdata.fda.gov |
| September 4, 1987 | K872233 | INJECT-EASE | KZH | Substantially Equivalent | Palco Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Insulin Vial Protector/Holder
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Magnifier, Hand-Held, Low-Vision
- All makers of Introducer, Syringe Needle
- All makers of LDQ
Updated June 28, 1995. 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.