Data / Medical devices / United States / Aim Medical Inc
Aim Medical Inc: FDA-registered device maker in Westwood, MA, United States, 2 510(k) clearances
Aim Medical Inc is registered with the FDA (registration 3012979524) in Westwood, MA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 16, 2017. 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
- 3012979524
- Address
- 360 University Ave, Westwood, MA, United States, 02090
- Owner or operator
- AIM Medical Inc (10052522)
- Roles
- Specification developer
- First device listed
- August 10, 2016
- Registered through
- 2027
- Brand names listed
- Dash Topic Lite Cream, Dash-Topic Plus Cream, ScarMD Pro Silicone Scar Gel, ScarMD Silicone Scar Gel, ScarMD Silicone Scar Spray, ScarMD Silicone Scar Sheet, ScarMD Silicone Scar Tape
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Specification developer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 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 16, 2017 | K171879 | HylaGuard Moisturizing Cream | MGQ | Substantially Equivalent | Founders Science Group, LLC | accessdata.fda.gov |
| April 21, 2016 | K150914 | Dash-Topic Plus Cream | FRO | Substantially Equivalent | Founders Science Group, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Occlusive
Updated October 16, 2017. 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.