Not currently registered with FDA under this name
Smith & Nephew, Inc.
Franklin Park, IL, United States. Named as applicant on 4 dental 510(k) clearances between 1986 and 1992. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 41986–1992
- Markets registered in
- 176,918 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 17 markets
Where regulators' registries name Smith & Nephew, 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 | Applicant | Smith & Nephew, Inc. | 4 clearances | 1986–1992 | Below |
| Canada | Health Canada | Registration holder | SMITH & NEPHEW, INC.SMITH & NEPHEW INC. | 2,752 | 1998–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Smith & Nephew Inc.Smith & Nephew,Inc. | 1,321 | — | Pure Global AI |
| Australia | TGA | Registration holder | Smith & Nephew Pty LtdSmith & Nephew Inc | 729 | 2003–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Smith & Nephew, Inc., | 485 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Smith & Nephew Inc.Smith & Nephew, Inc. · Smith & Nephew Inc · +2 | 296 | 1998–2026 | Pure Global AI |
| Singapore | HSA | Registration holder | SMITH & NEPHEW PTE. LIMITEDSmith & Nephew Inc. · Smith & Nephew, Inc. · +2 | 255 | 2004–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SMITH & NEPHEW, INCSMITH & NEPHEW INC · SMITH & NEPHEW INC. | 239 | 2017–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Smith & Nephew, Inc. | 229 | 2022–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SMITH AND NEPHEW, INCSMITH & NEPHEW, INC. · SMITH & NEPHEW. INC · +2 | 168 | — | Pure Global AI |
| Hong Kong | MDD | Registration holder | Smith & Nephew LimitedSmith & Nephew, Inc. · Smith & Nephew Inc. · +1 | 150 | 2009–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | SMITH & NEPHEW INC.SMITH & NEPHEW INC · SMITH & NEPHEW, INC. · +2 | 99 | — | Pure Global AI |
| China | NMPA | Registration holder | 美国施乐辉有限公司Smith & Nephew, Inc.美国施乐辉有限公司Smith & Nephew Inc. · 美国施乐辉有限公司 Smith & Nephew, Inc. · +2 | 76 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SMITH & NEPHEW, INC.Smith & Nephew, Inc. · SMITH & NEPHEW INC. · +2 | 56 | 1998–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Smith&Nephew Inc.Smith & Nephew Inc. · Smith & Nephew, Inc · +2 | 49 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SMITH & NEPHEW, INC.SMITH & NEPHEW, INC | 13 | 2014–2021 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Smith & Nephew, Inc. | 1 | — | 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
510(k) clearances
Clearances on which FDA names Smith & Nephew, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Sep 1992 | K923285 | PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE | ECB Air and/or Water Syringe Unit |
| 30 Sep 1991 | K913030 | MAX-I-PROBE IRRIGATION SYSTEM | EFS Oral Irrigation Unit |
| 4 Nov 1987 | K864294 | HENKE-JECT PRESSURE SYRINGE (MODIFICATION) | EGM Mechanical-Powered Jet Injector |
| 18 Nov 1986 | K864307 | MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) | EIC Irrigating Endodontic Periodontic Syringe |
Sources
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 of the most recent filing, which can be a US agent.