Data / Medical devices / Tray, Start/Stop (Including Contents), Dialysis

Tray, Start/Stop (Including Contents), Dialysis (FKG): 16 FDA-registered makers in 7 countries

Name: FDA-registered makers of Tray, Start/Stop (Including Contents), Dialysis
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

16 establishments in 7 countries are registered with the FDA to make Tray, Start/Stop (Including Contents), Dialysis (product code FKG, Class 1, 21 CFR 876.5820). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on May 3, 1995, and lists 8 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code: FKG
Device class: 1
Regulation: 876.5820
Medical specialty: Gastroenterology, Urology

Makers by country

Country	Makers
United States	7
Mexico	3
Pakistan	2
Israel	1
Honduras	1
Turkey	1
Germany	1

Makers of Tray, Start/Stop (Including Contents), Dialysis

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	Recall events	Source
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Astute Choice Packaging	Henrico, VA, United States	Manufacturer	0	api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305	Toano, VA, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Busse Hospital Disposables	Hauppauge, NY, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Centurion Medical Products, LP	Howell, MI, United States	Manufacturer, Repackager or relabeler	1	api.fda.gov
Cardinal Health 200, LLC	El Paso, TX, United States	Manufacturer	0	api.fda.gov
Convertors de Mexico S. de R.L. de C.V	CD.JUAREZ Chihuahua, Mexico	Manufacturer, Repackager or relabeler	0	api.fda.gov
Euroband Bioline LTD.	INDUSTRIAL PARK EMEK HEFER Central, Israel	Manufacturer, Specification developer	0	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0	api.fda.gov
Honduras Kitting, S.A.	Villanueva Cortes, Honduras	Contract manufacturer	0	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	Contract manufacturer	0	api.fda.gov
Maryam Trading	SIALKOT Punjab, Pakistan	Manufacturer	0	api.fda.gov
Medical Action Industries, Inc. 306	Arden, NC, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0	api.fda.gov
Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. S.	Tekirdag, Turkey	Contract manufacturer, Manufacturer	0	api.fda.gov
Symmetry Surgical GmbH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0	api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.	MEXICALI Baja California, Mexico	Manufacturer, Repackager or relabeler	0	api.fda.gov

Updated May 3, 1995. 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.