Hanson Medical, Inc.
Paso Robles, CA, US
HANSON MEDICAL, INC. appears in FDA device records in Paso Robles, CA. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Hanson Medical, Inc. between 1997 and 2014. The busiest year on record is 1997, with 7. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 7 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K141822 | SENSEI X ROBOTIC CATHETER SYSTEM | DXX | Substantially Equivalent | |
| K090803 | HANSON MEDICAL FACIAL IMPLANTS | FZE | Substantially Equivalent | |
| K071018 | MONARCH NASAL IMPLANT | FZE | Substantially Equivalent | |
| K041690 | MONARCH NASAL IMPLANT | FZE | Substantially Equivalent | |
| K040307 | HANSON SCAR ADE | MDA | Substantially Equivalent | |
| K030809 | HANSON MEDICAL GLUTEAL IMPLANT | MIB | Substantially Equivalent | |
| K030808 | HANSON MEDICAL CALF IMPLANT | MIB | Substantially Equivalent | |
| K973730 | DURASIL I AND DURASIL II | MIB | Substantially Equivalent | |
| K973729 | POWERFLEX PEC IMPLANT | MIC | Substantially Equivalent | |
| K973728 | SILICONE CARVING BLOCK | MIB | Substantially Equivalent | |
| K973573 | DURALASTIC ANATOMICAL NASAL IMPLANTS | FZE | Substantially Equivalent | |
| K973575 | DURALASTIC ANATOMICAL CHIN IMPLANTS | FWP | Substantially Equivalent | |
| K973574 | DURALASTIC ANATOMICAL MALAR IMPLANT | LZK | Substantially Equivalent | |
| K973572 | KELOCOTE SCAR GEL AND KELOCOTE LASER GEL | MDA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031444 | 3001890623 | HANSON MEDICAL, INC. | 3527 Combine Street, PASO ROBLES, CA 93446 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Hanson Medical, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain