Data / Medical devices / United States / Marine Polymer Technologies, Inc.
Marine Polymer Technologies, Inc.: FDA-registered device maker in Topsfield, MA, United States, 5 510(k) clearances
Marine Polymer Technologies, Inc. is registered with the FDA (registration 1225598) in Topsfield, MA, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 31, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1225598
- FEI number
- 3001237365
- Address
- 461 Boston ST., Unit B5, Topsfield, MA, United States, 01983
- Owner or operator
- MARINE POLYMER TECHNOLOGIES, INC. (9029754)
- Roles
- Manufacturer
- First device listed
- January 31, 2006
- Registered through
- 2027
- Brand names listed
- GLYKOSL, MRDH Bandage, SYVEKEXCEL VASCULAR AS, Syvek Brace, Syvek Radial Band, Syvek Radial Patch, SyvekExcel Patch, SyvekNT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 31, 2014 | K132293 | SYVEK RADIAL BAND | DXC | Substantially Equivalent | Marine Polymer Technologies | accessdata.fda.gov |
| July 28, 2010 | K102002 | TALYMED | FRO | Substantially Equivalent | Marine Polymer Technologies | accessdata.fda.gov |
| October 14, 2008 | K082703 | MRDH BANDAGE | KMF | Substantially Equivalent | Marine Polymer Technologies, Inc. | accessdata.fda.gov |
| March 28, 2006 | K053300 | SYVEKEXCEL | DXC | Substantially Equivalent | Marine Polymer Technologies, Inc. | accessdata.fda.gov |
| December 18, 1998 | K984177 | MODIFICATION TO SKVEKPATCH | KMF | Substantially Equivalent for Some Indications | Marine Polymer Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bandage, Liquid
- All makers of Dressing, Wound, Drug
- All makers of Support, Patient Position
- All makers of Clamp, Vascular
- All makers of Dressing, Wound, Hydrophilic
Updated July 31, 2014. 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.