LivaNova USA, INC. (contract manufacturer, Arvada, CO): 5 new FDA device listings, incl. catheter, cannula and tubing, vascular, cardiopulmonary bypass
LivaNova USA, INC. (Arvada, Colorado): 5 new FDA device listings, incl. catheter, cannula and tubing, vascular, cardiopulmonary bypass. Its amount of 5 is above the median of 1 (87th percentile). Dated 147 days ago, it serves as a historical benchmark. 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: 5 · 87th percentile of 2,570 DeviceEstablishmentPulse records · 5.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 32 related CO DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | LivaNova USA, INC. |
| Owner / operator | LivaNova |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer); Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Arvada, CO, US |
| New listings | 5 |
| Devices | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Dilator, Vessel, For Percutaneous Catheterization |
| Product codes | DWF, DRE |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | Venous Return Cannula; EasyFlow and EasyFlow Duo; Dual Stage Venous Cannula; RAP Cannula; ProtekDilate Vascular Access Kit |
| First new listing | 2026-06-11 |
| Latest new listing | 2026-06-11 |
| FDA registration number | 1718850 |
| Registration expires | 2027-12-31 |
| amount percentile | 87th of 2,570 (median 1, 5.0x median) |
| Peer records CSV (33 CO records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-06-11
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (CO first): Simple Style Inc (specification developer, Brighton, CO) · Paragon 28 (manufacturer, Englewood, CO) · Terumo BCT STERILIZATION SERVICES, Inc. (contract sterilizer · Altivera Medical, Inc. (repackager or relabeler, Englewood, · Covidien (specification developer, Lafayette, CO) · 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: LivaNova USA, INC. and 33 Colorado peers
- Colorado DeviceEstablishmentPulse records like this one: 33
- LivaNova USA, INC.'s amount: 87th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Colorado peer: $6,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for LivaNova USA, INC. in Arvada, Colorado?
LivaNova USA, INC. (Arvada, CO), a contract manufacturer, added 5 FDA device listings on 2026-06-11.
How does LivaNova USA, INC. compare to other Colorado DeviceEstablishmentPulse records?
Its amount of 5 sits in the upper half (87th percentile) of 2,570 records; the median is 1. It is 147 days old; check the official source for later updates before acting. Its Score of 80/100 puts it among the stronger signals in this feed.
LivaNova USA, INC. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| LivaNova USA, INC. | Arvada, CO | 5 | 87th | 2026-06-11 |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN | 4 | 83rd | 2026-10-16 |
| Cook Medical LLC | Bloomington, IN | 4 | 83rd | 2026-10-13 |
| Swiss-American CDMO,LLC | Carrollton, TX | 4 | 83rd | 2026-10-12 |
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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.