Dental Device Guide
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Manufacturer registered with FDA

Kirwan Surgical Products, Inc.

Marshfield, MA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator1219619Manufacturer
Device types listed
1
Brands and models
2
510(k) clearances
11990–1990
Markets registered in
13943 registrations outside the US
Establishments
1United States
1990: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 13 markets

Where regulators' registries name Kirwan Surgical Products, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedEuropean Union: 769 registrationsCanada: 92 registrationsAustralia: 29 registrationsSouth Korea: 11 registrationsTaiwan: 10 registrationsCosta Rica: 8 registrationsUnited Kingdom: 7 registrationsIsrael: 6 registrationsPeru: 4 registrationsSerbia: 4 registrationsSaudi Arabia: 2 registrationsColombia: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerKirwan Surgical Products, Inc.1 clearances1990–1990Below
European UnionEUDAMEDManufacturerKirwan Surgical Products LLC769—Pure Global AI
CanadaHealth CanadaRegistration holderKIRWAN SURGICAL PRODUCTS, LLC921999–2026Pure Global AI
AustraliaTGAManufacturerKirwan Surgical Products LLCKirwan Surgical Products Inc292007–2024Pure Global AI
South KoreaMFDSManufacturerKirwan Surgical Products LLCKIRWAN SURGICAL PRODUCTS INC. · Kirwan Surgical Products Inc · +2111999–2026Pure Global AI
TaiwanTFDAManufacturerKIRWAN SURGICAL PRODUCTS, LLC.KIRWAN SURGICAL PRODUCTS, INC.102005–2022Pure Global AI
Costa RicaMinisterio de SaludManufacturerKIRWAN SURGICAL PRODUCTS , LLCKirwan Surgical Products, LLC8—Pure Global AI
United KingdomMHRAManufacturerKirwan Surgical Products LLC7—Pure Global AI
IsraelAMARManufacturerKirwan Surgical Products LLCKirwan Surgical products LLC6—Pure Global AI
PeruDIGEMIDManufacturerKIRWAN SURGICAL PRODUCTS LLCKIRWAN SURGICAL PRODUCTS, LLC.42017–2025Pure Global AI
SerbiaALIMSManufacturerKirwan Surgical Products LLC42021–2024Pure Global AI
Saudi ArabiaSFDAManufacturerKirwan Surgical Products LLC2—Pure Global AI
ColombiaINVIMAManufacturerKIRWAN SURGICAL PRODUCTS, LLC1—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 Kirwan Surgical Products, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker
ChiselOsteotome
1992

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Kirwan Surgical Products, Inc. as the applicant.

Decided510(k)DeviceDevice type
13 Aug 1990K901896ENDOMETRIAL SAMPLEREJF Orthodontic Metal Bracket

Registered establishments

EstablishmentLocationWhat it does
KIRWAN SURGICAL PRODUCTS, LLC.FDA reg. 1219619MARSHFIELD, MA, United StatesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1219619). 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.