Not currently registered with FDA under this name

Wallach Surgical Devices, Inc.

Orange, CT, United States. Named as applicant on 1 dental 510(k) clearance between 2000 and 2000. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12000–2000
Markets registered in: 35 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 3 markets

Where regulators' registries name Wallach Surgical Devices, Inc. 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	Wallach Surgical Devices, Inc.	1 clearances	2000–2000	Below
Australia	TGA	Manufacturer	Wallach Surgical Devices Inc	4	2014–2014	Pure Global AI
Taiwan	TFDA	Manufacturer	WALLACH SURGICAL DEVICES, INC.	1	1986–1986	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 Wallach Surgical Devices, Inc. as the applicant.

Decided	510(k)	Device	Device type
11 Apr 2000	K000768	WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR	EKZ Dental Electrosurgical Unit and Accessories

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.