FUJIFILM Healthcare Americas Corporation (manufacturer, Lexington, MA): 9 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic

FUJIFILM Healthcare Americas Corporation (Lexington, Massachusetts): 9 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic. Its amount of 9 is top-decile (92nd percentile of 2,570 records). Dated 35 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: 9 · 92th percentile of 2,570 DeviceEstablishmentPulse records · 9.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 69 related MA DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentFUJIFILM Healthcare Americas Corporation
Owner / operatorFujifilm Corporation
RoleManufacturer
Establishment typesManufacture Medical Device
LocationLexington, MA, US
New listings9
DevicesSystem, Imaging, Pulsed Doppler, Ultrasonic; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic
Product codesIYN, ITX, IYO
Device classesClass II
Medical specialtiesRadiology
Brand namesCC13HPB5; S12BP4 Neurosurgery Probe; UST-9150; C9150LA
First new listing2026-06-10
Latest new listing2026-09-30
FDA registration number1000513161
Registration expires2026-12-31
amount percentile92th of 2,570 (median 1, 9.0x median)
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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

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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: FUJIFILM Healthcare Americas Corporation and 70 Massachusetts peers

  • Massachusetts DeviceEstablishmentPulse records like this one: 70
  • FUJIFILM Healthcare Americas Corporation's amount: 92nd percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Massachusetts peer: $14,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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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 FUJIFILM Healthcare Americas Corporation in Lexington, Massachusetts?

FUJIFILM Healthcare Americas Corporation (Lexington, MA), a manufacturer, added 9 FDA device listings between 2026-06-10 and 2026-09-30.

How does FUJIFILM Healthcare Americas Corporation compare to other Massachusetts DeviceEstablishmentPulse records?

This is a top-decile record: its amount of 9 is 9.0x the median of 1 across 2,570 records. It is 35 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.

FUJIFILM Healthcare Americas Corporation vs. top 2 peers

OrganizationLocationAmountPercentileRecord dateCompare
FUJIFILM Healthcare Americas CorporationLexington, MA992nd2026-09-30This record
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA688th2026-10-16Compare FUJIFILM Healthcare Americas Corporation vs Boston Scientific Corp., Marina Bay Cust. Fulfillment Center →
Beacon Biosignals, Inc.Boston, MA377th2026-10-16View record →

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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.

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