Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807616

FEI Number

3002807616

Entity Name

MEDISPEC, LTD.

City/State/Country

YEHUD Central, IL

Establishment Address

40 HATAASIYA ST., YEHUD Central 56101, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDISPEC, LTD. (Owner Number: 9006433)

Owner / Operator Contact Address

203 Perry Parkway, SUITE 6, Gaithersburg, MD 20877, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Econolith E3000 Econolith EM1000 ECONOLITH Model 2000 Lithotripter System Omnispec ED1000 Alma Duo Urospec Endo Comfort Lithospec SlimSpec Nephrospec Vascuspec Alma Duo RADIALSPEC Cardiospec Omnispec Model Orthospec Radialspec Neo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2005-07-18
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2005-07-18
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2010-11-22
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2005-07-18
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-02-06
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2005-07-18
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2024-03-20
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2009-04-14
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2006-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

Avner Spector Business: MEDISPEC, LTD. Email: spector@medispec-int.com Phone: (240) 5527310

Related Public Records

Same Entity

MEDISPEC, LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K885255	Candela Laser Corp.	MDL-1 LASERTRIPTER(TM)	1989-06-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2024	Getinge Usa Sales Inc	1	Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

Similar Registrations

Registration Number	Establishment Name	Location
3029915542	HUONS MEDITECH CO., LTD	Seongnam-si Gyeonggi, KR
1061158	STORZ MEDICAL AMERICA, INC.	Kennesaw, GA, US
9613347	STORZ MEDICAL AG	TAEGERWILEN Thurgau, CH
9611388	DORNIER MEDTECH GMBH	WESSLING Bavaria, DE
3017140415	INITIA, LTD.	Petah Tikva Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807616. Last updated year: 2026. Please use registration number 3002807616 when referencing this establishment in official correspondence.