DeviceEstablishmentPulse / report

Topcon Healthcare, Inc. (manufacturer, Oakland, NJ): 9 new FDA device listings, incl. refractometer, ophthalmic

Topcon Healthcare, Inc. (Oakland, New Jersey): 9 new FDA device listings, incl. refractometer, ophthalmic. Its amount of 9 is top-decile (92nd percentile of 2,570 records). Dated 119 days ago, it serves as a historical benchmark. Score 85/100. 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 13 published fields of this record are shown below. Locked: 48 related NJ DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentTopcon Healthcare, Inc.
RoleManufacturer
Establishment typesManufacture Device in the United States for Export Only
LocationOakland, NJ, US
New listings9
DevicesRefractometer, Ophthalmic; Tonometer, Ac-Powered; Camera, Ophthalmic, Ac-Powered; Microscope, Specular; Tomography, Optical Coherence; Refractor, Manual, Non-Powered, Including Phoropter; Biomicroscope, Slit-Lamp, Ac-Powered; Microscope, Operating & Accessories, Ac-Powered, Ophthalmic; Chart, Visual Acuity
Product codesHKO, HKX, HKI, NQE, OBO, HKN, HJO, HRM, HOX
Device classesClass I, Class II
Medical specialtiesOphthalmic, General, Plastic Surgery
First new listing2026-07-08
Latest new listing2026-07-08
FDA registration number2242863
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: 2026-07-08
  • 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: Topcon Healthcare, Inc. and 49 New Jersey peers

  • New Jersey DeviceEstablishmentPulse records like this one: 49
  • Topcon Healthcare, Inc.'s amount: 92nd percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every New Jersey peer: $9,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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85 / 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.

What is the DeviceEstablishmentPulse record for Topcon Healthcare, Inc. in Oakland, New Jersey?

Topcon Healthcare, Inc. (Oakland, NJ), a manufacturer, added 9 FDA device listings on 2026-07-08.

How does Topcon Healthcare, Inc. compare to other New Jersey 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 119 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.

Topcon Healthcare, Inc. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Topcon Healthcare, Inc.Oakland, NJ992nd2026-07-08
Paragon 28Englewood, CO992nd2026-10-08
Boston Scientific CorporationCoventry, RI1093rd2026-10-16
Abyrx, Inc.Stamford, CT790th2026-10-07

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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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