Data / Medical devices / El Salvador / Icat S.A. De C.V.

Icat S.A. De C.V.: FDA-registered device maker in San Salvador, El Salvador, 3 510(k) clearances

Name: Icat S.A. De C.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Icat S.A. De C.V. is registered with the FDA (registration 3005748481) in San Salvador, El Salvador. It lists 19 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 14, 1999. 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 Icat S.A. De C.V.

FDA registration number: 3005748481
Address: KM 12.5 Carretera Troncal del Norte Apopa, San Salvador, El Salvador, n/a
Owner or operator: ICAT S.A. de C.V. (10040106)
Roles: Contract manufacturer, Exporter to the US
First device listed: March 8, 2012
Registered through: 2026
Brand names listed: Barrier Supreme Drapes and Standard Supreme Drapes, Barrier Supreme Sterilization Wrapper, Encompass, Encompass Group LLC, George Courey Inc, MEDLINE INDUSTRIES, LP - Northfield, ProTexa L2 Surgical Gown, STC ID Code CB1 Comply Adult Briefs & Diapers and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Binder, Breast	HEF	1	Contract manufacturer	accessdata.fda.gov
Binder, Medical, Therapeutic	MDR	1	Contract manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Contract manufacturer	accessdata.fda.gov
Cover, Mattress (Medical Purposes)	FMW	1	Contract manufacturer	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Contract manufacturer	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Contract manufacturer	accessdata.fda.gov
Dress, Surgical	FYE	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Contract manufacturer	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Contract manufacturer	accessdata.fda.gov
Gown, Examination	FME	1	Contract manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Lift, Patient, Non-Ac-Powered	FSA	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Contract manufacturer	accessdata.fda.gov
Suit, Surgical	FXO	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Contract manufacturer, Exporter to the US	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 14, 1999	K982058	ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN	FYA	Substantially Equivalent	Encompass Group, LLC	accessdata.fda.gov
October 28, 1992	K921243	CONVERTORS STERILIZATION WRAP	FRG	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
October 11, 1991	K913506	CONVERTORS SAFECARE GOWN & DRAPE MATERIAL	KKX	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov

Compare with other makers

Updated January 14, 1999. 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.