Not currently registered with FDA under this name

Medelco , Ltd.

Stratford, CT, United States. Named as applicant on 1 dental 510(k) clearance between 1985 and 1985. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
11985–1985
Markets registered in
210 registrations outside the US
Establishments
0—
1985: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 2 markets

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

All markets
United States: 1 clearancesPeru: 10 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantMedelco , Ltd.1 clearances1985–1985Below
PeruDIGEMIDRegistration holderMEDELCO S.R.L.102013–2026Pure 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 Medelco , Ltd. as the applicant.

Decided510(k)DeviceDevice type
2 Dec 1985K853767FLOSPIKJES Dental Floss

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.