Data / Medical devices / United States / F. M. Howell & Co.
F. M. Howell & Co.: FDA-registered device maker in Elmira, NY, United States, 4 510(k) clearances
F. M. Howell & Co. is registered with the FDA (registration 3007366413) in Elmira, NY, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 28, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007366413
- Address
- 100 E. Miller ST., P. O. Box 286, Elmira, NY, United States, 14902
- Owner or operator
- F.M. HOWELL & CO. (1313700)
- Roles
- Repackager or relabeler
- First device listed
- November 18, 2004
- Registered through
- 2026
- Brand names listed
- BIOJECT VIAL ADAPTER, BlueSkyBio
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Adaptor, Hygiene | ILS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | 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 |
|---|---|---|---|---|---|---|
| March 28, 2008 | K073713 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Blue Sky Bio, LLC | accessdata.fda.gov |
| May 5, 2006 | K060957 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Blue Sky Bio, LLC | accessdata.fda.gov |
| September 2, 2005 | K051507 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Blue Sky Bio, LLC | accessdata.fda.gov |
| June 10, 2002 | K021833 | MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Blue Sky Bio | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Adaptor, Hygiene
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Tray, Impression, Preformed
Updated March 28, 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.