Not currently registered with FDA under this name

Prosurg, Inc.

San Jose, CA, United States. Named as applicant on 2 dental 510(k) clearances between 2007 and 2007. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
22007–2007
Markets registered in
699 registrations outside the US
Establishments
0—
2007: 2200020102020

510(k) clearances per year, 2000–2026

Registered in 6 markets

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

All markets
United States: 2 clearancesThailand: 71 registrationsCanada: 24 registrationsTaiwan: 2 registrationsSaudi Arabia: 1 registrationsSouth Korea: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantProsurg, Inc.2 clearances2007–2007Below
ThailandThai FDAManufacturerPROSURG, INC71—Pure Global AI
CanadaHealth CanadaRegistration holderPROSURG, INC.242000–2016Pure Global AI
TaiwanTFDAManufacturerPROSURGPROSURG, INC.22003–2012Pure Global AI
Saudi ArabiaSFDAManufacturerProsurg, Inc1—Pure Global AI
South KoreaMFDSManufacturerProsurg,Inc12002–2002Pure 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 Prosurg, Inc. as the applicant.

Decided510(k)DeviceDevice type
28 Dec 2007K072528ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIESJEY Bone Plate
25 Jul 2007K070737XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIESJEY 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.