Data / Medical devices / Tray, Biopsy, Without Biopsy Instruments

Tray, Biopsy, Without Biopsy Instruments (FCH): 18 FDA-registered makers in 5 countries

Name: FDA-registered makers of Tray, Biopsy, Without Biopsy Instruments
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

18 establishments in 5 countries are registered with the FDA to make Tray, Biopsy, Without Biopsy Instruments (product code FCH, Class 1, 21 CFR 876.4730). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on July 28, 1988, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: FCH
Device class: 1
Regulation: 876.4730
Medical specialty: Gastroenterology, Urology

Makers by country

Country	Makers
United States	11
Mexico	3
China	2
Pakistan	1
Honduras	1

Makers of Tray, Biopsy, Without Biopsy Instruments

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
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, Manufacturer for export, Repackager or relabeler	2	api.fda.gov
Devicor Medical Products, Inc.	Cincinnati, OH, United States	Specification developer	0	api.fda.gov
Diversatek Healthcare Inc	Milwaukee, WI, United States	Manufacturer	0	api.fda.gov
Dynamic Diagnostics Incorporated	Plymouth, MI, United States	Manufacturer	0	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0	api.fda.gov
HK Surgical, Inc.	San Clemente, CA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Honduras Kitting, S.A.	Villanueva Cortes, Honduras	Contract manufacturer	0	api.fda.gov
MEDLINE INDUSTRIES, LP - Laredo	Laredo, TX, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Medline Industries, LP - SPT	Waukegan, IL, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, Mexico	Manufacturer, Repackager or relabeler	0	api.fda.gov
Medline Soluciones Medicas	Nuevo Laredo Tamaulipas, Mexico	Manufacturer, Repackager or relabeler	0	api.fda.gov
Productos Medline S.A. De C.V.	NUEVO LAREDO Tamaulipas, Mexico	Manufacturer	0	api.fda.gov
Tessy Plastics Shanghai Co., Ltd	Shanghai, China	Contract manufacturer	0	api.fda.gov
Trinity Sterile, Inc.	Salisbury, MD, United States	Manufacturer	0	api.fda.gov
Therapak, LLC	Oakwood, GA, United States	Manufacturer	0	api.fda.gov
Uramix, Inc.	E Lansdowne, PA, United States	Specification developer	0	api.fda.gov
Xinhua Surgical Instrument Co. Ltd.	ZIBO Shandong, China	Manufacturer	0	api.fda.gov

Updated July 28, 1988. 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.