Philips Ultrasound LLC (manufacturer, Bothell, WA): 36 new FDA device listings, incl. catheter, ultrasound, intravascular
Philips Ultrasound LLC (Bothell, Washington): 36 new FDA device listings, incl. catheter, ultrasound, intravascular. Its amount of 36 is top-decile (99th percentile of 2,570 records). Dated 36 days ago, it serves as a historical benchmark. Score 95/100. 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: 36 · 99th percentile of 2,570 DeviceEstablishmentPulse records · 36.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 9 related WA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Philips Ultrasound LLC |
| Owner / operator | Philips Medical Systems International BV |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Bothell, WA, US |
| New listings | 36 |
| Devices | Catheter, Ultrasound, Intravascular; System, Image Processing, Radiological; System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic; Automated Radiological Image Processing Software; System, Imaging, Pulsed Doppler, Ultrasonic; Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Product codes | OBJ, LLZ, IYO, ITX, QIH, IYN, POK |
| Device classes | Class II |
| Medical specialties | Cardiovascular, Radiology |
| Brand names | Affiniti Series Diagnostic Ultrasound System; EPIQ Inspira Series Diagnostic Ultrasound System; C10-3v; D5cwc; mC7-2; Alturion Series Diagnostic Ultrasound System; S5-1; mL26-8 |
| First new listing | 2026-06-09 |
| Latest new listing | 2026-09-30 |
| FDA registration number | 3019216 |
| Registration expires | 2026-12-31 |
| amount percentile | 99th of 2,570 (median 1, 36.0x median) |
| Peer records CSV (10 WA 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: 2026-09-30
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (WA first): Mackay Manufacturing, Inc. (contract manufacturer, Spokane V · Siemens Medical Solutions USA, Inc. (manufacturer, Issaquah, · Fujifilm Sonosite,Inc. (manufacturer, Bothell, WA) · Acme United Corp. (repackager or relabeler, Vancouver, WA) · Titanlinks Logistics LLC (repackager or relabeler, Newark, D · 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: Philips Ultrasound LLC and 10 Washington peers
- Washington DeviceEstablishmentPulse records like this one: 10
- Philips Ultrasound LLC's amount: 99th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Washington peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
95 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Philips Ultrasound LLC in Bothell, Washington?
Philips Ultrasound LLC (Bothell, WA), a manufacturer, added 36 FDA device listings between 2026-06-09 and 2026-09-30.
How does Philips Ultrasound LLC compare to other Washington DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 36 is 36.0x the median of 1 across 2,570 records. It is 36 days old, still within a typical 45-day follow-up window. Its Score of 95/100 puts it among the stronger signals in this feed.
Philips Ultrasound LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Philips Ultrasound LLC | Bothell, WA | 36 | 99th | 2026-09-30 |
| Boston Scientific Corporation | Saint Paul, MN | 24 | 98th | 2026-10-16 |
| Ge Parallel Design, Inc. | Phoenix, AZ | 19 | 97th | 2026-10-07 |
| Surgentec LLC | Boca Raton, FL | 15 | 96th | 2026-10-16 |
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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.