Data / Medical devices / Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) (KHJ): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) (product code KHJ, Class 2, 21 CFR 874.3620). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on August 18, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KHJ
- Device class
- 2
- Regulation
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| United Kingdom | 2 |
| India | 1 |
| Dominican Republic | 1 |
| Germany | 1 |
Makers of Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
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 |
|---|---|---|---|---|---|---|---|---|
| Cook Biotech, Inc. | West Lafayette, IN, United States | Manufacturer | 4 | May 24, 2024 | 0 | 1 | 0 | api.fda.gov |
| Apatech Ltd. | ELSTREE Hertfordshire, United Kingdom | Manufacturer | 2 | January 24, 2007 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 2 | September 18, 1998 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Complaint file establishment, Manufacturer | 2 | May 2, 1997 | 0 | 0 | 0 | api.fda.gov |
| Exmoor Plastics Limited | Chorley Lancashire, United Kingdom | Manufacturer | 1 | November 19, 1991 | 0 | 0 | 0 | api.fda.gov |
| Grace Medical, Inc. | Memphis, TN, United States | Complaint file establishment, Manufacturer | 1 | August 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Invotec International, Inc. | Jacksonville, FL, United States | Manufacturer, Repackager or relabeler | 1 | December 6, 2005 | 0 | 0 | 0 | api.fda.gov |
| Merz North America, Inc. | Sturtevant, WI, United States | Manufacturer | 1 | January 9, 2002 | 0 | 0 | 0 | api.fda.gov |
| Merz North America, Inc. | Franksville, WI, United States | Manufacturer | 1 | January 9, 2002 | 0 | 0 | 0 | api.fda.gov |
| Orca Products LLC | Dothan, AL, United States | Specification developer | 1 | April 13, 2006 | 0 | 0 | 0 | api.fda.gov |
| Aegis Lifesciences Private Limited | Ahmedabad Gujarat, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 18, 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.