Registered with FDA
Olympus Corporation
HACHIOJI-SHI, Japan. Lists 4 dental device types with FDA across 3 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 3
- 510(k) clearances
- 12007–2007
- Markets registered in
- 173,739 registrations outside the US
- Establishments
- 3Germany, United States
510(k) clearances per year, 2000–2026
Registered in 17 markets
Where regulators' registries name Olympus Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Olympus Corporation | 1 clearances | 2007–2007 | Below |
| Canada | Health Canada | Registration holder | GYRUS ACMI, INCGYRUS ACMI, INC. · OLYMPUS WINTER & IBE GMBH | 1,189 | 1999–2026 | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | OLYMPUS WINTER & IBE GMBH | 948 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Gyrus ACMI, Inc.Olympus Winter & Ibe GmbH · OLYMPUS Winter & Ibe GmbH · +2 | 266 | 1999–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Gyrus ACMI, Inc.Olympus Winter & Ibe GmbH | 225 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Olympus Winter & Ibe GmbHGyrus ACMI, Inc. | 172 | 2022–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Gyrus Acmi IncOlympus Winter & Ibe GmbH | 166 | 2005–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Olympus Winter & IBEGyrus ACMI, Inc. | 156 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OLYMPUS WINTER & IBE GMBHGyrus ACMI, Inc. · OLYMPUS WINTER & IBE GmbH · +2 | 132 | 1979–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Gyrus ACMI Inc.Gyrus ACMI, Inc. | 122 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | OLYMPUS WINTER & IBE GMBHGYRUS ACMI, INC · GYRUS ACMI, INC. · +1 | 89 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | OLYMPUS WINTER & IBE GmbHOlympus Winter & Ibe GmbH · Gyrus ACMI, Inc · +1 | 81 | — | Pure Global AI |
| China | NMPA | Registration holder | 奥林巴斯苇音特和意北公司Olympus Winter & Ibe GmbH捷锐士股份有限公司Gyrus ACMI, Inc. · 奥林巴斯苇音特和意北公司 Olympus Winter & Ibe GmbH · +2 | 55 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Olympus Winter & Ibe GmbHGyrus ACMI, Inc. · Gyrus ACMI, Inc · +2 | 44 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | OLYMPUS WINTER & IBE GMBHGYRUS ACMI INC. · GYRUS ACMI, INC. · +1 | 36 | 2002–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GYRUS ACMI, INCOLYMPUS WINTER & IBE GMBH · OLYMPUS WINTER & IBE GmbH | 31 | 2015–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Olympus Winter & Ibe GmbHGyrus ACMI, Inc. | 27 | 2013–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Olympus Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Nose and Throat Ear CementNEA · Class 2 | — | Lister | Otomimix Otologic cement | 2008 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Lister | — | 2008 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2025 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Lister | Kartush Hydroxlapatite DisksPorous Hydroxlapatite granules | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Olympus Corporation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Walter Lorenz Surgical, Inc. (1), Richards Medical Co., Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Nov 2004 | K042516 | OTOMIMIX | Walter Lorenz Surgical, Inc. | NEA Nose and Throat Ear Cement |
| 29 Dec 1986 | K863237 | HYDROXYLAPATITE BONE GRAFT MATERIAL | Richards Medical Co., Inc. | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Gyrus ACMI, Inc.FDA reg. 3011050570 | Brooklyn Park, MN, United States | Complaint file establishment |
| GYRUS ACMI, INC.FDA reg. 1037007 | BARTLETT, TN, United States | Repacker / relabeler |
| OLYMPUS WINTER & IBE GMBHFDA reg. 9610773 | HAMBURG, Germany | Foreign exporter |
Other names on FDA records
Gyrus ACMI, Inc. · Olympus Winter & IBE
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9067818). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.