Not currently registered with FDA under this name

Codman & Shurtleff, Inc.

Raynham, MA, United States. Named as applicant on 3 dental 510(k) clearances between 2000 and 2001. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
32000–2001
Markets registered in
10364 registrations outside the US
Establishments
0—
2000: 22001: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 10 markets

Where regulators' registries name Codman & Shurtleff, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 3 clearancesSaudi Arabia: 172 registrationsSouth Korea: 54 registrationsTaiwan: 42 registrationsHong Kong: 36 registrationsIsrael: 18 registrationsCosta Rica: 15 registrationsColombia: 13 registrationsBrazil: 11 registrationsPeru: 3 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantCodman & Shurtleff, Inc.3 clearances2000–2001Below
Saudi ArabiaSFDAManufacturerCodman & Shurtleff, IncCodman & Shurtleff, Inc. · Codman and Shurtleff, Inc.172—Pure Global AI
South KoreaMFDSManufacturerCodman & Shurtleff, Inc.Codman & Shurtleff, Inc · Codman & Shurtleff,Inc · +1541998–2009Pure Global AI
TaiwanTFDAManufacturerCODMAN & SHURTLEFF,INC.Codman & Shurtleff, Inc.421978–2013Pure Global AI
Hong KongMDDManufacturerCodman & Shurtleff, Inc.Codman & Shurtleff, Inc362011–2019Pure Global AI
IsraelAMARManufacturerCodman & Shurtleff, Inc.18—Pure Global AI
Costa RicaMinisterio de SaludManufacturerCodman & Shurtleff Inc.Codman & Shurtleff, Inc15—Pure Global AI
ColombiaINVIMAManufacturerCODMAN & SHURTLEFF INC.CODMAN & SHURTLEFF, INC13—Pure Global AI
BrazilANVISAManufacturerCODMAN & SHURTLEFF INC.CODMAN & SHURTLEFF INC · CODMAN & SHURTLEFF, INC · +1112019–2019Pure Global AI
PeruDIGEMIDManufacturerCODMAN & SHURTLEFF INCCODMAN & SHURTLEFF32011–2017Pure 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 Codman & Shurtleff, Inc. as the applicant.

Decided510(k)DeviceDevice type
15 Feb 2001K003549CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETSJEY Bone Plate
6 Dec 2000K002798CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITSJEY Bone Plate
1 Aug 2000K992905CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEMJEY Bone Plate

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.