Data / Medical devices / United States / Navajo Manufacturing Company
Navajo Manufacturing Company: FDA-registered device maker in Denver, CO, United States, 5 510(k) clearances
Navajo Manufacturing Company is registered with the FDA (registration 3006140792) in Denver, CO, United States. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 21, 2010. Registered through 2026. FDA data exported November 3, 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
- 3006140792
- Address
- 601 W 50TH Ave, Denver, CO, United States, 80216
- Owner or operator
- Navajo Manufacturing Company Inc. (1720839)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- June 28, 2007
- Registered through
- 2026
- Brand names listed
- Denture Brush, Ear Plugs, Good to Go Toothbrush, HANDY SOLUTIONS FIRST AID KIT REGULAR, Handy Solutions, Handy Solutions Toothbrush, Tampax 3ct, Trojan Magnum Large Size XL Condom
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Soft Lens Products | LPN | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Case, Contact Lens | LRX | 2 | Complaint file establishment | accessdata.fda.gov |
| Condom | HIS | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Complaint file establishment | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Complaint file establishment | accessdata.fda.gov |
| Protector, Hearing (Insert) | EWD | U | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Complaint file establishment, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| July 21, 2010 | K101043 | ECT DIGITAL THERMOMETER | FLL | Substantially Equivalent | Changshan Estar Electronics Co., Ltd. | accessdata.fda.gov |
| August 1, 2006 | K061486 | TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES) | HEB | Substantially Equivalent | Procter & Gamble Co. | accessdata.fda.gov |
| August 30, 2000 | K002319 | PURILENS SALINE SOLUTION | LPN | Substantially Equivalent | Purilens, Inc. | accessdata.fda.gov |
| June 6, 2000 | K991206 | BONASSE CONTACT LENS CASE | LRX | Substantially Equivalent | Bonasse Ent. Co., Ltd. | accessdata.fda.gov |
| March 7, 1988 | K874383 | MENTOR PLUS (CONDOM) | HIS | Substantially Equivalent | Arcon Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Floss, Dental
- All makers of Condom
- All makers of Protector, Hearing (Insert)
- All makers of Toothbrush, Manual
- All makers of Continuous Measurement Thermometer
- All makers of Accessories, Soft Lens Products
Updated July 21, 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.