Data / Medical devices / United States / Ascend Eagle, Inc.
Ascend Eagle, Inc.: FDA-registered device maker in Pinole, CA, United States, 3 510(k) clearances
Ascend Eagle, Inc. is registered with the FDA (registration 2954902) in Pinole, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 15, 2010. Registered through 2027. 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
- 2954902
- FEI number
- 3003243726
- Address
- 828 San Pablo Avenue, Pinole, CA, United States, 94564
- Owner or operator
- ASCEND EAGLE, INC. (9044112)
- Roles
- Specification developer
- First device listed
- November 2, 2005
- Registered through
- 2027
- Brand names listed
- Cranberry, MULTIPLE PRIVATE LABELS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 15, 2010 | K101351 | NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT | LZA | Substantially Equivalent | Ascend Eagle, Inc. | accessdata.fda.gov |
| April 15, 2010 | K092472 | NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT | LZA | Substantially Equivalent | Ascend Eagle, Inc. | accessdata.fda.gov |
| January 25, 2006 | K052666 | NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN | LYY | Substantially Equivalent | Ascend Eagle, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 15, 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.