Data / Medical devices / Retainer, Surgical / United States

FDA-registered makers of Retainer, Surgical in the United States: 18 establishments

Name: FDA-registered makers of Retainer, Surgical in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

18 establishments in the United States are registered with the FDA to make Retainer, Surgical (product code GCZ). 1 has a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device: Retainer, Surgical
Product code: GCZ
Country: United States

Makers of Retainer, Surgical in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Adept-Med Intl., Inc.	Diamond Springs, CA, United States	Manufacturer	2	March 19, 1987	0	api.fda.gov
Alira Medical Devices LLC	Rancho Cucamonga, CA, United States	Specification developer	0		0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Cook Incorporated	Bloomington, IN, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	0		0	api.fda.gov
Folsom Metal Products, Inc.	Pelham, AL, United States	Complaint file establishment, Manufacturer	0		1	api.fda.gov
Greer Medical, Inc.	Santa Barbara, CA, United States	Specification developer	0		0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0		0	api.fda.gov
Kalitec Direct LLC DBA Kalitec Medical	Sarasota, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Mendell	Lakeville, MN, United States	Contract manufacturer	0		0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	0		0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Rainbow Medical Devices LLC	Mission Viejo, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	api.fda.gov
STERIS Corporation	Saint Louis, MO, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Toby Orthopaedics	Miami, FL, United States	Manufacturer	0		0	api.fda.gov

Updated November 2, 2026. 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.