AOMORI OLYMPUS CO., LTD. Kuroishi Site (manufacturer, KUROISHI-SHI Aomori, JP): 6 new FDA device listings, incl. hemostatic metal clip for the gi tract

AOMORI OLYMPUS CO., LTD. Kuroishi Site (KUROISHI-SHI Aomori): 6 new FDA device listings, incl. hemostatic metal clip for the gi tract. Its amount of 6 is above the median of 2 (88th percentile). Dated 65 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-11-04, 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: 6 · 88th percentile of 2,709 DeviceEstablishmentPulse records · 3.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 60 related JP DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentAOMORI OLYMPUS CO., LTD. Kuroishi Site
Owner / operatorOlympus Corporation
RoleManufacturer
Establishment typesManufacture Medical Device
LocationKUROISHI-SHI Aomori, JP
New listings6
DevicesHemostatic Metal Clip For The Gi Tract; Forceps, Biopsy, Electric; Gastroscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Instrument, Ultrasonic Surgical; Electrosurgical, Cutting & Coagulation & Accessories
Product codesPKL, KGE, FDS, FAS, LFL, GEI
Device classesClass II, Unclassified
Medical specialtiesGastroenterology, Urology, General, Plastic Surgery
Brand namesHX-610-135XS; HX-610-135S; HX-610-135; HX-610-090L; HX-610-090S; HX-610-090; HX-610-135L; FD-412LR
First new listing2026-06-16
Latest new listing2026-09-01
FDA registration number9614641
Registration expires2027-12-31
amount percentile88th of 2,709 (median 2, 3.0x 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: 2026-09-01
  • Data refreshed: 2026-11-04
  • 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, 04 Nov 2026 21:52:36 GMT

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Peer benchmark and outreach value: AOMORI OLYMPUS CO., LTD. Kuroishi Site and 61 JP peers

  • JP DeviceEstablishmentPulse records like this one: 61
  • AOMORI OLYMPUS CO., LTD. Kuroishi Site's amount: 88th percentile of 2,709 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every JP peer: $12,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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75 / 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.

What is the DeviceEstablishmentPulse record for AOMORI OLYMPUS CO., LTD. Kuroishi Site in KUROISHI-SHI Aomori?

AOMORI OLYMPUS CO., LTD. Kuroishi Site (KUROISHI-SHI Aomori, JP), a manufacturer, added 6 FDA device listings between 2026-06-16 and 2026-09-01.

How does AOMORI OLYMPUS CO., LTD. Kuroishi Site compare to other DeviceEstablishmentPulse records?

Its amount of 6 sits in the upper half (88th percentile) of 2,709 records; the median is 2. It is 65 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.

AOMORI OLYMPUS CO., LTD. Kuroishi Site vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JP688th2026-09-01
Inter-Med, Inc.Racine, WI586th2026-10-22
Centerpoint Systems LLCWest Valley City, UT586th2026-10-21
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLCWaukesha, WI586th2026-10-19

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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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