Philips Ultrasound LLC (contract manufacturer, Reedsville, PA): 32 new FDA device listings, incl. transducer, ultrasonic, diagnostic
Philips Ultrasound LLC (Reedsville, Pennsylvania): 32 new FDA device listings, incl. transducer, ultrasonic, diagnostic. Its amount of 32 is top-decile (98th percentile of 2,570 records). Dated 36 days ago, it serves as a historical benchmark. Score 90/100. 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: 32 · 98th percentile of 2,570 DeviceEstablishmentPulse records · 32.0x 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 | Philips Ultrasound LLC |
| Owner / operator | Philips Medical Systems International BV |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device; Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Reedsville, PA, US |
| New listings | 32 |
| Devices | Transducer, Ultrasonic, Diagnostic; Automated Radiological Image Processing Software; System, Image Processing, Radiological; Catheter, Ultrasound, Intravascular; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Product codes | ITX, QIH, LLZ, OBJ, IYN, IYO, POK |
| Device classes | Class II |
| Medical specialties | Radiology, Cardiovascular |
| Brand names | Affiniti Series Diagnostic Ultrasound System; Epiq Series Diagnostic Ultrasound System; EPIQ Inspira Series Diagnostic Ultrasound System; Koios DS; eV14-2v Transducer; C10-3v; D5cwc; mC7-2 |
| First new listing | 2026-06-09 |
| Latest new listing | 2026-09-30 |
| FDA registration number | 2518586 |
| Registration expires | 2026-12-31 |
| amount percentile | 98th of 2,570 (median 1, 32.0x median) |
| Peer records CSV (44 PA 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 (PA first): 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 · Sound Technology Inc. (manufacturer, State College, PA) · 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 44 Pennsylvania peers
- Pennsylvania DeviceEstablishmentPulse records like this one: 44
- Philips Ultrasound LLC's amount: 98th 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)
90 / 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.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Philips Ultrasound LLC in Reedsville, Pennsylvania?
Philips Ultrasound LLC (Reedsville, PA), a contract manufacturer, added 32 FDA device listings between 2026-06-09 and 2026-09-30.
How does Philips Ultrasound LLC compare to other Pennsylvania DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 32 is 32.0x 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 90/100 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 | Reedsville, PA | 32 | 98th | 2026-09-30 |
| Zimmer, Inc. | Warsaw, IN | 28 | 98th | 2026-09-29 |
| Millstone Medical Outsourcing LLC. | Fall River, MA | 24 | 98th | 2026-10-08 |
| Biopro, Inc. | Port Huron, MI | 11 | 94th | 2026-10-15 |
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.