Data / Medical devices / United States / Newmedical Technology, Inc.
Newmedical Technology, Inc.: FDA-registered device maker in Northbrook, IL, United States, 2 510(k) clearances
Newmedical Technology, Inc. is registered with the FDA (registration 3005369309) in Northbrook, IL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 30, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005369309
- Address
- 4065 Commercial Avenue, Northbrook, IL, United States, 60062
- Owner or operator
- NEWMEDICAL TECHNOLOGY, INC. (9064417)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 10, 2007
- Registered through
- 2026
- Brand names listed
- DevraSorb Polyurethane Foam AWC Dressing, LIPOLOCK, MYNEWGEL, NXGEL Silicone Gel for Scar Management, NXGEL Silicone Sheeting, NewGel+ Silicone Sheeting, NewGel+E Silicone Gel for Scar Management, NewGel+UV Silicone Gel for Scars + SPF30 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | 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 |
|---|---|---|---|---|---|---|
| November 30, 2012 | K121361 | CURALINE POLYURETHANE FOAM AWC DRESSING | FRO | Substantially Equivalent | Curaline, Inc. | accessdata.fda.gov |
| October 17, 2005 | K041704 | NEWGEL AND NEWGEL PLUS E | MDA | Substantially Equivalent | Newmedical Technology, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 30, 2012. 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.