Manufacturer registered with FDA
ARTHREX Inc.
Naples, FL, United States. Lists 2 dental device types with FDA across 8 registered establishments.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 103,477 registrations outside the US
- Establishments
- 8Australia, Canada, Chile +3
Registered in 10 markets
Where regulators' registries name ARTHREX Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | ARTHREX Inc. | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | ARTHREX INC | 2,052 | 1999–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | ARTHREX INC.ARTHREX INC · ARTHREX | 447 | — | Pure Global AI |
| Australia | TGA | Registration holder | Arthrex Australia Pty Ltd | 416 | 2004–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ARTHREX, INC.ARTHREX INC. · ARTHREX INC · +1 | 241 | 2016–2026 | Pure Global AI |
| Singapore | HSA | Registration holder | ARTHREX SINGAPORE, PTE. LTD.Arthrex, Inc. · Arthrex Inc., · +1 | 152 | 2008–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ARTHREX, INCARTHREX INC | 111 | 2008–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ARTHREX INC.ARTHREX, INC. · Arthrex, Inc. · +1 | 46 | 2003–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | ARTHREX Inc. | 11 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Arthrex Manufacturing, Inc. | 1 | 2023–2023 | 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 ARTHREX Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | AR-200 - Clips | 2021 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Forceps, Rongeur, Surgical | 2023 |
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
ARTHREX Inc. 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: W&H Dentalwerk Buermoos GmbH (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 May 2002 | K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
| 7 Feb 2001 | K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Arthrex Australia Pty Ltd.FDA reg. 3019269298 | Frenchs Forest New South Wales, Australia | Foreign exporter |
| Arthrex Chile SPAFDA reg. 3027339877 | Pudahuel Region Metropolitana, Chile | Foreign exporter |
| Arthrex Colombia SASFDA reg. 3021226419 | Bogota Cundinamarca, Colombia | Foreign exporter |
| Arthrex Logistic Center CanadaFDA reg. 3030926959 | London Ontario, Canada | Foreign exporter |
| Arthrex Manufacturing Inc.FDA reg. 3015231789 | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer |
| Arthrex Singapore Pte Ltd.FDA reg. 3014004349 | Singapore Central Singapore, Singapore | Foreign exporter |
| Arthrex, Inc.FDA reg. 3010331645 | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer |
| ARTHREX, INC.FDA reg. 1220246 | Naples, FL, United States | Specification developer |
Other names on FDA records
Arthrex Australia Pty Ltd · Arthrex Singapore, Pte. Ltd. · Arthrex Manufacturing, Inc. · Arthrex Colombia SAS · Arthrex Chile SPA · Arthrex Logistic Center Canada
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1220287). 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.