Data / Medical devices / Instrument, Surgical, Disposable / United States

FDA-registered makers of Instrument, Surgical, Disposable in the United States: 61 establishments

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

61 establishments in the United States are registered with the FDA to make Instrument, Surgical, Disposable (product code KDC). 3 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.

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Device: Instrument, Surgical, Disposable
Product code: KDC
Country: United States

Makers of Instrument, Surgical, Disposable in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Axiom Medical, Inc.	Torrance, CA, United States	Manufacturer	2	March 15, 1982	0	api.fda.gov
Dravon Medical, Inc.	Clackamas, OR, United States	Manufacturer	1	September 26, 1983	0	api.fda.gov
Summit Medical LLC	Saint Paul, MN, United States	Contract manufacturer, Manufacturer	1	October 14, 1983	0	api.fda.gov
Acra Cut, Inc.	Acton, MA, United States	Manufacturer	0		0	api.fda.gov
Advanced Product Solutions Inc.	Dothan, AL, United States	Contract manufacturer	0		0	api.fda.gov
Ahn Surgical Innovation LLC	Desoto, TX, United States	Specification developer	0		0	api.fda.gov
ARCH-MedTorque	Kenosha, WI, United States	Contract manufacturer	0		0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Abbott Medical	Plymouth, MN, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Abbott Medical	Saint Paul, MN, United States	Manufacturer	0		0	api.fda.gov
Ansell Sandel Medical Solutions LLC	Chatsworth, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Bonds Therapeutics	Columbiana, OH, United States	Specification developer	0		0	api.fda.gov
Busse Hospital Disposables	Hauppauge, NY, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Bard Access Systems, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
C.R. Bard, Inc.	Covington, GA, United States	Contract sterilizer, Specification developer	0		0	api.fda.gov
Centurion Medical Products, LP	Williamston, MI, United States	Specification developer	0		0	api.fda.gov
Centurion Medical Products, LP	Howell, MI, United States	Manufacturer, Repackager or relabeler	0		1	api.fda.gov
Customfab, Inc.	Anaheim, CA, United States	Contract manufacturer	0		0	api.fda.gov
Cardinal Health	Hazelwood, MO, United States	Specification developer	0		0	api.fda.gov
Cook Incorporated	Bloomington, IN, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Deroyal Industries, Inc.	Maynardville, TN, United States	Contract manufacturer	0		0	api.fda.gov
Deroyal Industries, Inc.	Powell, TN, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Deroyal Industries, Inc.	New Tazewell, TN, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
Deroyal Industries, Inc.	Maynardville, TN, United States	Contract manufacturer	0		0	api.fda.gov
Design Standards Corp.	Charlestown, NH, United States	Contract manufacturer	0		0	api.fda.gov
DR Innovations, LLC Dba Sensiband	Summit, NJ, United States	Specification developer	0		0	api.fda.gov
DRMR LLC	Centerville, OH, United States	Manufacturer	0		0	api.fda.gov
DeRoyal Industries, Inc.	New Tazewell, TN, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
DeRoyal Industries, Inc.	Powell, TN, United States	Contract manufacturer	0		0	api.fda.gov
Ethicon, Inc.	Somerville, NJ, United States	Manufacturer	0		1	api.fda.gov
Ethicon, Inc.	Raritan, NJ, United States	Specification developer	0		0	api.fda.gov
Ethicon, LLC	Guaynabo, PR, United States	Manufacturer	0		0	api.fda.gov
Ethicon, LLC.	San Lorenzo, PR, United States	Manufacturer	0		0	api.fda.gov
Footprint Medical Inc.	San Antonio, TX, United States	Manufacturer	0		0	api.fda.gov
Juna Corporation	Wilmington, DE, United States	Specification developer	0		0	api.fda.gov
Kapp Surgical, Inc.	Cleveland, OH, United States	Manufacturer	0		0	api.fda.gov
Koda Ideaworks Inc	Waunakee, WI, United States	Specification developer	0		0	api.fda.gov
Lee Medical	Seneca, SC, United States	Manufacturer	0		0	api.fda.gov
MEDLINE INDUSTRIES, LP - Laredo	Laredo, TX, United States	Manufacturer, Repackager or relabeler, Reprocessor	0		0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Specification developer	0		2	api.fda.gov
Merit Medical Systems, Inc.	South Jordan, UT, United States	Specification developer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
Medegen Medical Products	Gallaway, TN, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Preferred Medical Products, LLC	Copperhill, TN, United States	Contract manufacturer	0		0	api.fda.gov
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0		0	api.fda.gov
Renovo, Inc.	Bend, OR, United States	Reprocessor	0		0	api.fda.gov
RSB Spine LLC.	Wooster, OH, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Saint-Gobain Performance Plastics	Portage, WI, United States	Contract manufacturer	0		0	api.fda.gov
Scanlan International, Inc.	Saint Paul, MN, United States	Manufacturer, Specification developer	0		1	api.fda.gov
Surgical Technologies, Inc.	St. Paul, MN, United States	Contract manufacturer	0		0	api.fda.gov
Surgistar, Inc.	Vista, CA, United States	Manufacturer	0		0	api.fda.gov
Syntr Health Technologies, Inc.	Irvine, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Sterling Medical Products	Prophetstown, IL, United States	Manufacturer	0		0	api.fda.gov
Trigon America LLC	Aurora, IL, United States	Contract manufacturer	0		0	api.fda.gov
TZ Medical, Inc.	Tualatin, OR, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Teleflex LLC (NADC)	Olive Branch, MS, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Teleflex Medical LLC	Morrisville, NC, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Vericel Corporation	Cambridge, MA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Welmed, Inc.	Chicago, IL, United States	Specification developer	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.