# Tela Bio, Inc. (manufacturer, Malvern, PA): 2 new FDA device listings, incl. mesh, surgical, polymeric

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Tela Bio, Inc. |
| Owner / operator | TELA Bio |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Malvern, PA, US |
| New listings | 2 |
| Devices | Mesh, Surgical, Polymeric; Mesh, Surgical |
| Product codes | FTL, FTM |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery |
| Brand names | Liora Monofilament Scaffold |
| First new listing | 2026-10-07 |
| Latest new listing | 2026-10-07 |
| FDA registration number | 3010513348 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.