Tela Bio, Inc. (manufacturer, Malvern, PA): 2 new FDA device listings, incl. mesh, surgical, polymeric
Tela Bio, Inc. (Malvern, Pennsylvania): 2 new FDA device listings, incl. mesh, surgical, polymeric. Its amount of 2 is above the median of 1 (69th percentile). Dated 28 days ago, it is in the active follow-up window. Score 80/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 43 related PA DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 69th of 2,570 (median 1, 2.0x median) |
| Peer records CSV (44 PA records) | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-10-07
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Tela Bio, Inc. and 44 Pennsylvania peers
- Pennsylvania DeviceEstablishmentPulse records like this one: 44
- Tela Bio, Inc.'s amount: 69th percentile of 2,570 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $8,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 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.
What is the DeviceEstablishmentPulse record for Tela Bio, Inc. in Malvern, Pennsylvania?
Tela Bio, Inc. (Malvern, PA), a manufacturer, added 2 FDA device listings on 2026-10-07.
How does Tela Bio, Inc. compare to other Pennsylvania DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 28 days old, still within a typical 45-day follow-up window. Its Score of 80/100 puts it among the stronger signals in this feed.
Tela Bio, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Tela Bio, Inc. | Malvern, PA | 2 | 69th | 2026-10-07 |
| Beacon Biosignals, Inc. | Boston, MA | 3 | 77th | 2026-10-16 |
| Endovascular Engineering, Inc. | Menlo Park, CA | 3 | 77th | 2026-10-14 |
| INNO Holdings Inc. | Millcreek, UT | 3 | 77th | 2026-10-05 |
Related records
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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.