Bear-Ent, LLC (manufacturer, Malvern, PA): 1 new FDA device listing, incl. press, vein
Bear-Ent, LLC (Malvern, Pennsylvania): 1 new FDA device listing, incl. press, vein. Its amount of 1 is above the median of 1 (50th percentile). Dated 169 days ago, it serves as a historical benchmark. Score 55/100. 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: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 43 related PA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Bear-Ent, LLC |
| Role | Manufacturer |
| Establishment types | Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198 |
| Location | Malvern, PA, US |
| New listings | 1 |
| Devices | Press, Vein |
| Product codes | JYW |
| Device classes | Class I |
| Medical specialties | Ear, Nose, Throat |
| Brand names | BEAR |
| First new listing | 2026-05-19 |
| Latest new listing | 2026-05-19 |
| FDA registration number | 3021680161 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x 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: 2026-05-19
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (PA first): Philips Ultrasound LLC (contract manufacturer, Reedsville, P · Arch Medical Solutions - Philadelphia, LLC Dba Jade Precisio · Globus Medical, Inc. (manufacturer, Audubon, PA) · Alta Smiles, LLC (manufacturer, Fort Washington, PA) · Synthes (USA) Products LLC (specification developer, West Ch · Browse all by state and category →
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: Bear-Ent, LLC and 44 Pennsylvania peers
- Pennsylvania DeviceEstablishmentPulse records like this one: 44
- Bear-Ent, LLC's amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $8,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Bear-Ent, LLC in Malvern, Pennsylvania?
Bear-Ent, LLC (Malvern, PA), a manufacturer, added 1 FDA device listing on 2026-05-19.
How does Bear-Ent, LLC compare to other Pennsylvania DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 169 days old; check the official source for later updates before acting.
Bear-Ent, LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Bear-Ent, LLC | Malvern, PA | 1 | 50th | 2026-05-19 |
| 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
DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Pennsylvania
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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.