Registered with FDA
Wexler Surgical Inc.
Houston, TX, United States. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 111,905 registrations outside the US
- Establishments
- 1United States
Registered in 11 markets
Where regulators' registries name Wexler Surgical 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 | Lister | Wexler Surgical Inc. | 10 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | WEXLER SURGICAL, INC. | 1,733 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Wexler Surgical, Inc.Wexler Surgical Inc. | 61 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Wexler Surgical Inc | 34 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Wexler Surgical, Inc.Wexler Surgical · Wexler Surgical Inc. · +2 | 31 | 2011–2023 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | WEXLER SURGICAL, INC. | 14 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | WEXLER SURGICAL | 12 | 2020–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | Wexler Surgical, Inc.WEXLER SURGICAL · Wexler Surgical | 6 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | WEXLER SURGICAL, INC | 6 | 2014–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | WEXLER SURGICALWEXLER SURGICAL, INC. · Wexler Surgical, Inc. | 5 | 2010–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | WEXLER SURGICALWEXLER SURGICAL, INC. | 3 | — | 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 Wexler Surgical 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 |
|---|---|---|---|---|
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Lister | — | 2006 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | — | 2006 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Lister | — | 2006 |
| Operative CuretteEKE · Class 1 | Dental hand instruments | Lister | — | 2006 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Lister | — | 2006 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Lister | — | 2006 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | — | 2006 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Lister | — | 2006 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Lister | — | 2006 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Lister | — | 2006 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| WEXLER SURGICAL, INC.FDA reg. 1646747 | HOUSTON, TX, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9008378). 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.