Data / Medical devices / United States / Amsel Medical Corporation
Amsel Medical Corporation: FDA-registered device maker in Cambridge, MA, United States, 1 510(k) clearance
Amsel Medical Corporation is registered with the FDA (registration 3008989837) in Cambridge, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 23, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008989837
- Address
- 705 Cambridge Street, Cambridge, MA, United States, 02141
- Owner or operator
- Amsel Medical Corporation (10054894)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 9, 2017
- Registered through
- 2026
- Brand names listed
- Amsel Occluder Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clip, Implantable | FZP | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| January 23, 2015 | K140932 | AMSEL OCCLUDER DEVICE | FZP | Substantially Equivalent | Amsel Medical Corporation | accessdata.fda.gov |
Compare with other makers
Updated January 23, 2015. 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.