Olympus Medical Systems Corp. (specification developer, HACHIOJI-SHI Tokyo, JP): 20 new FDA device listings, incl. endoscopic video imaging system/component, gastroenterology-urology
Olympus Medical Systems Corp. (HACHIOJI-SHI Tokyo): 20 new FDA device listings, incl. endoscopic video imaging system/component, gastroenterology-urology. Its amount of 20 is top-decile (97th percentile of 2,709 records). Dated 21 days ago, it is in the active follow-up window. Score 85/100. 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: 20 · 97th percentile of 2,709 DeviceEstablishmentPulse records · 10.0x 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.
| Field | Value |
|---|---|
| Establishment | Olympus Medical Systems Corp. |
| Owner / operator | Olympus Corporation |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility; Export Device to the United States But Perform No Other Operation on Device |
| Location | HACHIOJI-SHI Tokyo, JP |
| New listings | 20 |
| Devices | Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Endoscope, Accessories, Narrow Band Spectrum; Gastroscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Hemostatic Metal Clip For The Gi Tract; Bronchoscope (Flexible Or Rigid); Instrument, Ultrasonic Surgical; Electrosurgical, Cutting & Coagulation & Accessories; Laparoscope, General & Plastic Surgery; Transducer, Ultrasonic, Diagnostic |
| Product codes | FET, NWB, FDS, FAS, PKL, EOQ, LFL, GEI, GCJ, ITX, ODG, PSV, KGE |
| Device classes | Class II, Unclassified |
| Medical specialties | Gastroenterology, Urology, Ear, Nose, Throat, General, Plastic Surgery, Radiology |
| Brand names | CH-S700-08-LB; GIF-2T1500; SD-230U-20; D-201-13404; HX-610-135XS; HX-610-135S; HX-610-135; HX-610-090L |
| First new listing | 2026-05-11 |
| Latest new listing | 2026-10-15 |
| FDA registration number | 8010047 |
| Registration expires | 2027-12-31 |
| amount percentile | 97th of 2,709 (median 2, 10.0x median) |
| Peer records CSV (61 JP 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: 2026-10-15
- 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: Olympus Medical Systems Corp. and 61 JP peers
- JP DeviceEstablishmentPulse records like this one: 61
- Olympus Medical Systems Corp.'s amount: 97th percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every JP peer: $12,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
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.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Olympus Medical Systems Corp. in HACHIOJI-SHI Tokyo?
Olympus Medical Systems Corp. (HACHIOJI-SHI Tokyo, JP), a specification developer (outsources manufacturing), added 20 FDA device listings between 2026-05-11 and 2026-10-15.
How does Olympus Medical Systems Corp. compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 20 is 10.0x the median of 2 across 2,709 records. It is 21 days old, still within a typical 45-day follow-up window. Its Score of 85/100 puts it among the stronger signals in this feed.
Olympus Medical Systems Corp. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, JP | 20 | 97th | 2026-10-15 |
| Boston Scientific Corporation | Marlborough, MA | 9 | 92nd | 2026-10-16 |
| Synthes (USA) Products LLC | West Chester, PA | 7 | 90th | 2026-10-23 |
| SHOULDER INNOVATIONS, Inc | Grand Rapids, MI | 7 | 90th | 2026-10-15 |
Related records
DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: Foreign establishment
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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.