Data / Medical devices / United States / SS Medical Products LLC
SS Medical Products LLC: FDA-registered device maker in North Bergen, NJ, United States, 3 510(k) clearances
SS Medical Products LLC is registered with the FDA (registration 2438948) in North Bergen, NJ, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 14, 2016. Registered through 2026. FDA data exported November 3, 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
- 2438948
- FEI number
- 3003396642
- Address
- 9243 John F. Kennedy Blvd., North Bergen, NJ, United States, 07047
- Owner or operator
- SS MEDICAL PRODUCTS LLC (9046146)
- Roles
- Repackager or relabeler
- First device listed
- March 5, 2008
- Registered through
- 2026
- Brand names listed
- GluStitch Twist, Gluseal 90, SkinSeal SNIP, SkinStitch, SkinStitch Twist, skinstitch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tissue Adhesive For The Topical Approximation Of Skin | MPN | 2 | Repackager or relabeler | 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 14, 2016 | K150032 | GluStitch Twist Tissue Adhesive | MPN | Substantially Equivalent | Glustitch, Inc. | accessdata.fda.gov |
| February 23, 2009 | K083752 | GLUSEAL 90, MODEL GLU9010 | KMF | Substantially Equivalent | Glustitch, Inc. | accessdata.fda.gov |
| August 21, 2003 | K030574 | GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER | KMF | Substantially Equivalent | Glustitch, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bandage, Liquid
- All makers of Bandage, Liquid, Skin Protectant
- All makers of Tissue Adhesive For The Topical Approximation Of Skin
Updated January 14, 2016. 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.