Data / Medical devices / Israel / Medispec, Ltd.

Medispec, Ltd.: FDA-registered device maker in YEHUD Central, Israel, 4 510(k) clearances and 2 PMA approvals

Name: Medispec, Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medispec, Ltd. is registered with the FDA (registration 3002807616) in YEHUD Central, Israel. It lists 7 device types. The FDA files 4 510(k) clearances and 2 PMA approvals under its listings, the newest dated January 27, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Medispec, Ltd.

FDA registration number: 3002807616
Address: 40 Hataasiya ST., YEHUD Central, Israel, 56101
Owner or operator: MEDISPEC, LTD. (9006433)
Roles: Contract manufacturer, Manufacturer
First device listed: July 18, 2005
Registered through: 2026
Brand names listed: Alma Duo, Cardiospec, ECONOLITH Model 2000 Lithotripter System, Econolith E3000, Econolith EM1000, Endo Comfort, Lilycare, Lithospec and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Digital Image Storage, Radiological	LMB	1	Manufacturer	accessdata.fda.gov
Generator, Shock-Wave, For Pain Relief	NBN	3	Contract manufacturer, Manufacturer	accessdata.fda.gov
Lithotriptor, Electro-Hydraulic	FFK	2	Manufacturer	accessdata.fda.gov
Lithotriptor, Extracorporeal Shock-Wave, Urological	LNS	2	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Manufacturer	accessdata.fda.gov
Table, Operating-Room, Ac-Powered	FQO	1	Manufacturer	accessdata.fda.gov
Uroflowmeter	EXY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 27, 2023	K210166	Omnispec ED1000	ISA	Substantially Equivalent	Medispec, Ltd.	accessdata.fda.gov
March 9, 2007	K063504	ECONOLITH EM1000	LNS	Substantially Equivalent	Medispec, Ltd.	accessdata.fda.gov
May 25, 2004	K040461	ECONOLITH E3000, MODEL 3000 (SW-6)	LNS	Substantially Equivalent	Medispec, Ltd.	accessdata.fda.gov
March 12, 1998	K974796	LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER	FFK	Substantially Equivalent	Medispec, Ltd.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
April 1, 2005	P040026	ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE	NBN	0	April 1, 2005	accessdata.fda.gov
April 7, 1997	P950043	ECONOLITH(TM) LITHOTRIPTER	LNS	5	August 27, 1999	accessdata.fda.gov

Compare with other makers

Updated January 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.