Not currently registered with FDA under this name

Downs Surgical , Ltd.

Wilmington, MA, United States. Named as applicant on 2 dental 510(k) clearances between 1982 and 1986. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 21982–1986
Markets registered in: 21 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1980–2026

Registered in 2 markets

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

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Downs Surgical , Ltd.	2 clearances	1982–1986	Below
Canada	Health Canada	Registration holder	DOWNS SURGICAL	1	1999–1999	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 Downs Surgical , Ltd. as the applicant.

Decided	510(k)	Device	Device type
25 Feb 1986	K854711	FIBRELIGHT ILLUMINATING ORAL RETRACTORS	EIG All Types Retractor
28 May 1982	K821358	MODIFIED RONGEURS FOR SPINAL & ORTH. S.	EMH Surgical Rongeur Forceps

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.