Manufacturer registered with FDA
Teleflex
Morrisville, NC, United States. Lists 14 dental device types with FDA across 2 registered establishments.
- Device types listed
- 14
- Brands and models
- 28
- 510(k) clearances
- 0as applicant
- Markets registered in
- 194,644 registrations outside the US
- Establishments
- 2United States
Registered in 19 markets
Where regulators' registries name Teleflex as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Teleflex | 14 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Teleflex Medical Sdn. Bhd.Teleflex Medical · Teleflex Medical LLC. · +1 | 1,797 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | TELEFLEX MEDICAL LLCTELEFLEX MEDICAL · TELEFLEX MEDICAL SDN. BHD. | 1,015 | 1998–2026 | Pure Global AI |
| India | CDSCO | Registration holder | Teleflex Medical Private Limited | 427 | 2018–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | TELEFLEX MEDICALTELEFLEX MEDICAL INCORPORATED. · TELEFLEX MEDICAL LLC · +2 | 296 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Teleflex MedicalTeleflex Medical Sdn Bhd · TELEFLEX MEDICAL, INC. · +2 | 240 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Teleflex Medical LLCTeleflex Medical · Teleflex Medical Sdn. Bhd. · +1 | 189 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Teleflex Medical LLCTeleflex Medical · Teleflex Medical Sdn Bhd | 143 | 2005–2026 | Pure Global AI |
| Malaysia | MDA | Registration holder | TELEFLEX MEDICAL SDN.BHD | 122 | 2022–2027 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TELEFLEX MEDICAL LLCTELEFLEX MEDICAL INCORPORATED · TELEFLEX MEDICAL · +2 | 86 | 2000–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Teleflex MedicalTeleflex Medical Sdn. Bhd. · TELEFLEX MEDICAL Sdn. Bhd. · +2 | 73 | 2002–2023 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Teleflex MedicalTeleflex Medical Sdn. Bhd. · Teleflex Medical Private Limited | 55 | 2023–2026 | Pure Global AI |
| China | NMPA | Registration holder | 爱尔兰泰利福医疗有限公司Teleflex Medical美国泰利福医疗有限公司Teleflex Medical · 美国泰利福医疗有限公司 Teleflex Medical LLC · +2 | 51 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Teleflex MedicalTELEFLEX MEDICAL SDN BHD · TELEFLEX MEDICAL. · +2 | 39 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Teleflex MedicalTeleflex Medical LLC · TELEFLEX MEDICAL · +1 | 39 | 1996–2022 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TELEFLEX MEDICALTELEFLEX MEDICAL LLC · TELEFLEX MEDICAL INC. | 25 | 2010–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Teleflex MedicalTeleflex medical · Teleflex Medical LLC | 24 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Teleflex MedicalTeleflex Medical LLC · Teleflex Medical Sdn. Bhd. · +2 | 20 | 2014–2026 | Pure Global AI |
| Philippines | FDA Philippines | Manufacturer | Teleflex Medical Inc. | 3 | 2025–2025 | 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 Teleflex currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MULTIPLE MOUTH MIRRORS | 2006 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | LIGHTMULTIPLE SURGICAL HEADLIGHT LIGHTSSURGICAL HEADLIGHT | 2006 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | PILLINGPINEHOLE | 2006 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | MULTIPLE IRRIGATING DENTAL SYRINGESPILLING | 2006 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | PILLINGRETRACTOR | 1995 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | CALCULUS REMOVALMULTIPLE CALCULUS REMPILLING | 2006 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | HEMOSTATMULTIPLE SURGICAL HEMOSTATSPILLING | 2006 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | MULTIPLE SURGICAL BIOPSY PUNCHESPILLING | 2006 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Pilling | 2007 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | MULTIPLE SURGICAL RONGEUR FORCEPSPILLING | 1995 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | KMEDICPilling | 1995 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | CURETTEPILLING | 2006 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | MULTIPLE SURGICAL BONE CHISELSPILLING | 2006 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | Pilling | 2007 |
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 |
|---|---|---|
| Teleflex LLC (NADC)FDA reg. 3010041511 | Olive Branch, MS, United States | Manufacturer, Repacker / relabeler |
| Teleflex Medical LLCFDA reg. 3011137372 | Morrisville, NC, United States | Complaint file establishment, Specification developer |
Other names on FDA records
Teleflex Medical Sdn. Bhd. · Teleflex LLC (NADC)
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9062981). 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.