Not currently registered with FDA under this name

Medrad, Inc.

Pittsburgh, PA, United States. Named as applicant on 1 dental 510(k) clearance between 1987 and 1987. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
11987–1987
Markets registered in
537 registrations outside the US
Establishments
0—
1987: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 5 markets

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

All markets
United States: 1 clearancesTaiwan: 16 registrationsSouth Korea: 15 registrationsColombia: 5 registrationsCosta Rica: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantMedrad, Inc.1 clearances1987–1987Below
TaiwanTFDAManufacturerMEDRAD INC.MEDRAD, INC. · medrad, inc.161988–2013Pure Global AI
South KoreaMFDSManufacturerMEDRAD.INC.MEDRAD, INC. · MEDRAD, Inc. · +2151999–2013Pure Global AI
ColombiaINVIMARegistration holderMEDRAD INC5—Pure Global AI
Costa RicaMinisterio de SaludManufacturerMedrad Inc1—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 Medrad, Inc. as the applicant.

Decided510(k)DeviceDevice type
24 Feb 1987K870243BURNETT TMJ APPLIANCEEAG Cephalometer

Some of these clearances are listed with FDA today by another company: Bayer Medical Care Inc. (1).

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.