Data / Medical devices / Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Polymer, Ear, Nose And Throat, Synthetic, Absorbable (NHB): 20 FDA-registered makers in 5 countries
20 establishments in 5 countries are registered with the FDA to make Polymer, Ear, Nose And Throat, Synthetic, Absorbable (product code NHB, Class 2, 21 CFR 874.3620). 9 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on July 30, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NHB
- Device class
- 2
- Regulation
- 874.3620
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 15 |
| Germany | 2 |
| France | 1 |
| Ireland | 1 |
| Netherlands | 1 |
Makers of Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Spirair, Inc | South San Francisco, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 3 | July 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 3 | November 10, 2019 | 0 | 1 | 0 | api.fda.gov |
| Spirair | Mountain View, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | July 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| 3-D Matrix Europe SAS | Caluire et Cuire Rhone, France | Specification developer | 1 | April 12, 2019 | 0 | 0 | 0 | api.fda.gov |
| 3-D Matrix, Inc. | Newton, MA, United States | Complaint file establishment, Manufacturer | 1 | April 12, 2019 | 0 | 1 | 0 | api.fda.gov |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 1 | February 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| Ethicon, Inc. | Raritan, NJ, United States | Manufacturer | 1 | February 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| Johnson & Johnson MEDICAL GmbH | NORDERSTEDT Schleswig-Holstein, Germany | Manufacturer | 1 | February 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| Stryker Ireland Ltd. Instruments Division, Innovation Centre | Carrigtwohill Cork(County), Ireland | Specification developer | 1 | May 7, 2007 | 0 | 0 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Davol Inc. | Woburn, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hemostasis, LLC | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MTD Micro Molding | Charlton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medeologix LLC | San Jose, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pharmpur GMBH | Konigsbrunn, Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polyganics Holding BV | Groningen, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Corp. | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Technologies, Inc. | St. Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spectrum Plastics Group | Saint Louis Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 30, 2026. 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.