Data / Medical devices / United States / Hanson Medical, Inc.
Hanson Medical, Inc.: FDA-registered device maker in Paso Robles, CA, United States, 9 510(k) clearances
Hanson Medical, Inc. is registered with the FDA (registration 2031444) in Paso Robles, CA, United States. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 30, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2031444
- FEI number
- 3001890623
- Address
- 3527 Combine Street, Paso Robles, CA, United States, 93446
- Owner or operator
- HANSON MEDICAL, INC. (9033292)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- March 17, 1998
- Registered through
- 2026
- Brand names listed
- Anatomical Chin Implant, Anatomical Malar Implants, Anatomical Nasal Implants, CALF IMPLANT, Dermatix, Dermatix C, Dermatix Gel, Dermatix Ultra and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Elastomer, Silicone Block | MIB | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Malar | LZK | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Muscle, Pectoralis | MIC | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Chin, Internal | FWP | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Nose, Internal | FZE | 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 30, 2010 | K090803 | HANSON MEDICAL FACIAL IMPLANTS | FZE | Substantially Equivalent | Hanson Medical, Inc. | accessdata.fda.gov |
| August 12, 2004 | K040307 | HANSON SCAR ADE | MDA | Substantially Equivalent | Hanson Medical, Inc. | accessdata.fda.gov |
| April 21, 2003 | K030809 | HANSON MEDICAL GLUTEAL IMPLANT | MIB | Substantially Equivalent | Hanson Medical, Inc. | accessdata.fda.gov |
| April 21, 2003 | K030808 | HANSON MEDICAL CALF IMPLANT | MIB | Substantially Equivalent | Hanson Medical, Inc. | accessdata.fda.gov |
| December 24, 1997 | K973729 | POWERFLEX PEC IMPLANT | MIC | Substantially Equivalent | Hanson Medical, Inc. | accessdata.fda.gov |
| November 13, 1997 | K973728 | SILICONE CARVING BLOCK | MIB | Substantially Equivalent | Hanson Medical, Inc. | accessdata.fda.gov |
| November 13, 1997 | K973573 | DURALASTIC ANATOMICAL NASAL IMPLANTS | FZE | Substantially Equivalent | Hanson Medical, Inc. | accessdata.fda.gov |
| November 7, 1997 | K973575 | DURALASTIC ANATOMICAL CHIN IMPLANTS | FWP | Substantially Equivalent | Hanson Medical, Inc. | accessdata.fda.gov |
| October 24, 1997 | K973574 | DURALASTIC ANATOMICAL MALAR IMPLANT | LZK | Substantially Equivalent | Hanson Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Nose, Internal
- All makers of Implant, Malar
- All makers of Elastomer, Silicone Block
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Implant, Muscle, Pectoralis
- All makers of Prosthesis, Chin, Internal
Updated June 30, 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.