Data / Medical devices / Catheter, Nephrostomy, General & Plastic Surgery

Catheter, Nephrostomy, General & Plastic Surgery (GBO): 29 FDA-registered makers in 10 countries

Name: FDA-registered makers of Catheter, Nephrostomy, General & Plastic Surgery
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

29 establishments in 10 countries are registered with the FDA to make Catheter, Nephrostomy, General & Plastic Surgery (product code GBO, Class 1, 21 CFR 878.4200). 0 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on August 19, 2004, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: GBO
Device class: 1
Regulation: 878.4200
Medical specialty: General, Plastic Surgery

Makers by country

Country	Makers
United States	14
India	4
Costa Rica	3
Taiwan	2
Egypt	1
Ireland	1
China	1
France	1
Denmark	1
Mexico	1

Makers of Catheter, Nephrostomy, General & Plastic Surgery

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
Allwin Medical Devices, Inc.	Anaheim, CA, United States	Manufacturer	0	api.fda.gov
Ameco Medical Industries	10TH OF RAMADAN CITY Ash Sharqiyah, Egypt	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Angiodynamics, Inc.	Queensbury, NY, United States	Manufacturer	0	api.fda.gov
Argon Medical Devices Inc.	Athens, TX, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Argon Medical Devices, Inc.	Wheeling, IL, United States	Contract manufacturer	0	api.fda.gov
AUSA Medical Device Pvt Ltd	Bangalore Karnataka, India	Contract manufacturer	0	api.fda.gov
Allwin Medical Devices Pvt. Ltd.	Surat Gujarat, India	Manufacturer	0	api.fda.gov
AngioDynamics, Inc.	Marlborough, MA, United States	Specification developer	0	api.fda.gov
Biorad Medisys Pvt. Ltd.	Pune Maharashtra, India	Manufacturer	0	api.fda.gov
Boston Scientific Corporation	Marlborough, MA, United States	Specification developer	1	api.fda.gov
Boston Scientific Corporation	La Aurora Heredia, Costa Rica	Specification developer	0	api.fda.gov
Boston Scientific Corporation	Spencer, IN, United States	Manufacturer	1	api.fda.gov
Biomerics Cartago	Cartago, Costa Rica	Contract manufacturer	0	api.fda.gov
Bioteque Corporation I-Lan Factory II	Su-Ao Cheng Yilan, Taiwan	Manufacturer	0	api.fda.gov
Bioteque Corporation Yilan Science Park Factory	Yilan City, Taiwan	Complaint file establishment, Manufacturer	0	api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center	Quincy, MA, United States	Manufacturer	0	api.fda.gov
Boston Scientific Corporation	El Coyol Alajuela, Costa Rica	Manufacturer	0	api.fda.gov
Boston Scientific Corporation	Coventry, RI, United States	Manufacturer	0	api.fda.gov
Boston Scientific Limited	GALWAY Galway(County), Ireland	Manufacturer	0	api.fda.gov
Canyon Medical Inc.	Nanjing Jiangsu, China	Manufacturer	0	api.fda.gov
Coloplast Manufacturing France, SAS	Sarlat la Caneda Cedex Dordogne, France	Manufacturer	0	api.fda.gov
Cook Medical LLC	Bloomington, IN, United States	Contract manufacturer	0	api.fda.gov
Cook Incorporated	Bloomington, IN, United States	Complaint file establishment, Manufacturer	1	api.fda.gov
Cook Incorporated	Spencer, IN, United States	Manufacturer	0	api.fda.gov
Mermaid Medical A/S	Stenloese Hovedstaden, Denmark	Manufacturer, Repackager or relabeler	0	api.fda.gov
SEI Medical S.A. de C.V.	Juarez Chihuahua, Mexico	Contract manufacturer	0	api.fda.gov
Suru International Pvt Ltd	DAHANU Maharashtra, India	Manufacturer	0	api.fda.gov
Teleflex Medical LLC	Morrisville, NC, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Uresil, LLC	Skokie, IL, United States	Manufacturer	0	api.fda.gov

Updated August 19, 2004. 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.