Data / Medical devices / Instrument, Manual, Surgical, General Use / United States

FDA-registered makers of Instrument, Manual, Surgical, General Use in the United States: 243 establishments

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

243 establishments in the United States are registered with the FDA to make Instrument, Manual, Surgical, General Use (product code MDM). 1 has a 510(k) clearance or PMA approval on file and 9 have a recall event. FDA data exported November 2, 2026.

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Device: Instrument, Manual, Surgical, General Use
Product code: MDM
Country: United States

Makers of Instrument, Manual, Surgical, General Use in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Edm 3, LLC	Jacksonville, FL, United States	Manufacturer, Repackager or relabeler	1	October 28, 1992	0	api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)	Riviera Beach, FL, United States	Contract manufacturer	0		0	api.fda.gov
4web Inc.	Frisco, TX, United States	Specification developer	0		0	api.fda.gov
Accurate Surgical & Scientific Instruments Corp.	Westbury, NY, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
AIMM, Inc.	Kingston, MA, United States	Specification developer	0		0	api.fda.gov
American Medicals	Jacksonville, FL, United States	Specification developer	0		0	api.fda.gov
Applied Medical Resources Corp.	Rsm, CA, United States	Complaint file establishment, Manufacturer	0		1	api.fda.gov
ARCH-MedTorque	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Armm, Inc.	Huntington Beach, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Arnold Tuber Industries	Orchard Park, NY, United States	Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0		1	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Atricure, Inc.	Mason, OH, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Aurora Surgical, LLC	St Petersburg, FL, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0		0	api.fda.gov
Automated Medical Products Corp.	Sewaren, NJ, United States	Specification developer	0		0	api.fda.gov
AVALIGN TECHNOLOGIES, Inc.	Fort Wayne, IN, United States	Specification developer	0		0	api.fda.gov
Aztec	Lakeville, MN, United States	Contract manufacturer	0		0	api.fda.gov
Able Medical Devices	Marquette, MI, United States	Contract manufacturer	0		0	api.fda.gov
AccuTec, Inc.	Verona, VA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Ansell Sandel Medical Solutions LLC	Chatsworth, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Applied Medical Distribution Center	Irvine, CA, United States	Manufacturer	0		0	api.fda.gov
Arthrex California Technology, Incorporated	Santa Barbara, CA, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Arthrex Logistic Center	Fort Myers, FL, United States	Manufacturer	0		0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
ArthroCare Corporation	Austin, TX, United States	Specification developer	0		0	api.fda.gov
AtriCure, Inc.	Pleasanton, CA, United States	Specification developer	0		0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
B & M Precision, Inc.	Ruskin, FL, United States	Contract manufacturer	0		0	api.fda.gov
Bard Shannon Limited	Humacao, PR, United States	Contract manufacturer	0		0	api.fda.gov
Be Innovative Medical Solutions, LLC	Denver, CO, United States	Manufacturer	0		0	api.fda.gov
Bear-Ent, LLC	Malvern, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Biomet Microfixation	Jacksonville, FL, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	0		1	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Black & Black Surgical, Inc.	Tucker, GA, United States	Specification developer	0		0	api.fda.gov
Bonds Therapeutics	Columbiana, OH, United States	Specification developer	0		0	api.fda.gov
Boston Scientific Corporation	Marlborough, MA, 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	Specification developer	0		0	api.fda.gov
Beaver-Visitec International, Inc.	Waltham, MA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Bimini Health Tech	Plano, TX, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Boston Scientific Corporation	Coventry, RI, United States	Manufacturer	0		0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
C&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, United States	Contract manufacturer	0		0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
C.R. Bard, Inc.	Covington, GA, United States	Complaint file establishment, Contract sterilizer, Specification developer	0		0	api.fda.gov
Carefusion 2200, Inc.	Vernon Hills, IL, United States	Specification developer	0		0	api.fda.gov
Carefusion 2200, Inc.	Mannford, OK, United States	Contract manufacturer	0		0	api.fda.gov
Carwild Corp.	New London, CT, United States	Contract manufacturer, 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	0		0	api.fda.gov
CIVCO Medical Instruments Co., Inc.	Coralville, IA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Classic Wire Cut Company, Inc.	Valencia, CA, United States	Contract manufacturer	0		0	api.fda.gov
Cole Instruments	Alpharetta, GA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Cook Vandergrift Inc.	Vandergrift, PA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	api.fda.gov
Cadence Science, Inc.	Cranston, RI, United States	Contract manufacturer	0		0	api.fda.gov
Cardinal Health	Hazelwood, MO, United States	Specification developer	0		0	api.fda.gov
Cislak Manufacturing, Inc.	Niles, IL, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
ClearPoint Neuro Inc.	Carlsbad, CA, United States	Manufacturer	0		0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0		0	api.fda.gov
Cook Incorporated	Bloomington, IN, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Davol Inc., Sub. C.R. Bard, Inc.	Warwick, RI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Deheer Orthopedics	Carmel, IN, United States	Specification developer	0		0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler, Specification developer	0		1	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	0		0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	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
Dieble Surgical LLC	North Lawrence, OH, United States	Specification developer	0		0	api.fda.gov
Distinctive Plastics, Inc.	Vista, CA, United States	Contract manufacturer	0		0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	api.fda.gov
DeRoyal Industries, Inc.	New Tazewell, TN, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
Delasco, LLC	Plano, TX, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Elliquence LLC	Baldwin, NY, United States	Specification developer	0		0	api.fda.gov
Elmed, Inc.	Glendale Heights, IL, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Encompass Group, LLC.	McDonough, GA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Endo Usa	Cranbury, NJ, United States	Specification developer	0		1	api.fda.gov
Ethicon Endo-Surgery, Inc.	Cincinnati, OH, United States	Specification developer	0		2	api.fda.gov
Ethicon Endo-Surgery, LLC	Guaynabo, PR, United States	Specification developer	0		0	api.fda.gov
Elite Medical, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Elite Medical, LLC	Florence, AL, United States	Contract manufacturer	0		0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Fetzer Surgical, LLC	Scottsdale, AZ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Fischer Surgical Inc.	Imperial, MO, United States	Manufacturer	0		0	api.fda.gov
G Surgical LLC	Austin, TX, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0		0	api.fda.gov
GLW, Inc.	Englewood Cliffs, NJ, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Griff Industries, Inc.	Lancaster, CA, United States	Contract manufacturer	0		0	api.fda.gov
Gsource, LLC.	Emerson, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
GT Metabolic Solutions, Inc.	Saint Michael, MN, United States	Manufacturer	0		0	api.fda.gov
Gyrus Acmi, Inc.	Westborough, MA, United States	Specification developer	0		0	api.fda.gov
GoldenDent	Roseville, MI, United States	Specification developer	0		0	api.fda.gov
Gyrus ACMI, Inc.	Brooklyn Park, MN, United States	Manufacturer	0		0	api.fda.gov
Hanes Industries	Conover, NC, United States	Specification developer	0		0	api.fda.gov
Hoht LLC	Danbury, CT, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Holmed LLC	Attleboro, MA, United States	Manufacturer	0		0	api.fda.gov
Hologic, Inc.	Marlborough, MA, United States	Specification developer	0		0	api.fda.gov
Hu-Friedy MFG Co., LLC	Des Plaines, IL, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Hu-Friedy MFG. Co. LLC	Northbrook, IL, United States	Manufacturer	0		0	api.fda.gov
Huron Tool & Cutter Grinding	Farmingdale, NY, United States	Contract manufacturer	0		0	api.fda.gov
Hydrofera, LLC.	Manchester, CT, United States	Contract manufacturer	0		0	api.fda.gov
Insightra Medical, Inc.	Clarksville, TN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Instrumental Machine & Development, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
International Sterilization Laboratory, LLC	Groveland, FL, United States	Contract sterilizer, Manufacturer for export	0		0	api.fda.gov
Instrumed International Inc dba Avalign German Specialty Instruments	Schaumburg, IL, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
Integra LifeSciences Production Corporation	Mansfield, MA, United States	Specification developer	0		0	api.fda.gov
Iridex Corporation	San Jose, CA, United States	Manufacturer	0		0	api.fda.gov
Iridex Corporation	Mountain View, CA, United States	Manufacturer	0		0	api.fda.gov
J & J Instruments, LLC	Northbrook, IL, United States	Specification developer	0		0	api.fda.gov
JMG Machine, Inc.	La Mirada, CA, United States	Contract manufacturer	0		0	api.fda.gov
Katena Products, Inc.	Fenton, MO, United States	Manufacturer	0		0	api.fda.gov
Katena Products, Inc.	Parsippany, NJ, United States	Specification developer	0		0	api.fda.gov
Katena Products, Inc.	Randolph, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Kinamed, Inc.	Camarillo, CA, United States	Contract manufacturer	0		0	api.fda.gov
Klann, Inc.	Waynesboro, VA, United States	Contract manufacturer	0		0	api.fda.gov
KLS-Martin L.P.	Jacksonville, FL, United States	Specification developer	0		0	api.fda.gov
Kmi Imi Group / Dba: Innovative Med, Inc.	Irvine, CA, United States	Manufacturer	0		0	api.fda.gov
Kaz USA, Inc., A Helen of Troy Company	Marlborough, MA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
LAB Medical Manufacturing, Inc.	Billerica, MA, United States	Contract manufacturer	0		0	api.fda.gov
Lenkbar LLC	Naples, FL, United States	Contract manufacturer	0		0	api.fda.gov
Lsi Solutions Inc.	Victor, NY, United States	Manufacturer	0		0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Manufacturer	0		0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer	0		0	api.fda.gov
Mainstream Medical Devices	Austin, TX, United States	Contract manufacturer	0		0	api.fda.gov
Mason Tayler Medical Products Corp.	Buffalo, NY, United States	Specification developer	0		0	api.fda.gov
Mastel Surgical Inc.	Schiller Park, IL, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Mci Medical Concept Innovation Inc.	Sunrise, FL, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Mclean Medical & Scientific	Saint Paul, MN, United States	Contract manufacturer	0		0	api.fda.gov
Medical Component Specialists	Bellingham, MA, United States	Contract 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	Complaint file establishment, Specification developer	0		3	api.fda.gov
Medtronic Navigation, Inc.	Lafayette, CO, United States	Manufacturer	0		0	api.fda.gov
Mentor	Irving, TX, United States	Specification developer	0		0	api.fda.gov
Merit Medical Systems, Inc.	South Jordan, UT, United States	Manufacturer	0		1	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Reprocessor	0		0	api.fda.gov
Microsurgery Instruments, Inc.	Bellaire, TX, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
MILLENNIUM MEDICAL TECHNOLOGIES INC./DBA Cellmyx	Carlsbad, CA, United States	Manufacturer	0		0	api.fda.gov
Mizuho America, Inc.	Union City, CA, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
MedSource Labs, LLC	Chanhassen, MN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Medegen Medical Products	Gallaway, TN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Medicraft Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Reprocessor	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
Nico Corporation	Indianapolis, IN, United States	Specification developer	0		0	api.fda.gov
Nordent MFG., Inc.	Elk Grove Village, IL, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
North Coast Medical, Inc.	Morgan Hill, CA, United States	Manufacturer	0		0	api.fda.gov
Northpoint Surgical LLC	Wayland, MA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Nvision Biomedical Technologies, Inc	San Antonio, TX, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Nypro Inc (Maple Grove)	Maple Grove, MN, United States	Contract manufacturer	0		0	api.fda.gov
Omt, LLC	Fort Lauderdale, FL, United States	Specification developer	0		0	api.fda.gov
Orbis Medical, LLC	Palmetto Bay, FL, United States	Specification developer	0		0	api.fda.gov
Orchid Orthopedics-Chelsea	Chelsea, MI, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	0		0	api.fda.gov
Orthopli Corp.	Philadelphia, PA, United States	Manufacturer	0		0	api.fda.gov
Osteomed	Addison, TX, United States	Manufacturer, Specification developer	0		0	api.fda.gov
On-X Life Technologies Inc.	Austin, TX, United States	Manufacturer	0		0	api.fda.gov
P&F Machining	Otsego, MN, United States	Manufacturer	0		0	api.fda.gov
Pacific Instruments Inc.	Honolulu, HI, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Parcus Medical, L.L.C.	Sarasota, FL, United States	Manufacturer	0		0	api.fda.gov
Phoenix Instruments, Inc.	Lisle, IL, United States	Contract manufacturer	0		0	api.fda.gov
Phoenix Medical Products, Inc.	Mountain City, TN, United States	Contract manufacturer	0		0	api.fda.gov
PMT Corp.	Chanhassen, MN, United States	Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Post Surgical MFG.	Bay Shore, NY, United States	Contract manufacturer	0		0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	api.fda.gov
Princeton Medical Group, Inc.	Franklin, TN, United States	Specification developer	0		0	api.fda.gov
Paragon Medical Inc.	Castleton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	api.fda.gov
Peregrine Surgical, LLC.	New Britain, PA, United States	Manufacturer	0		0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Portal Access Inc	Miami Beach, FL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Power Dental USA, Inc.	McHenry, IL, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Precision Edge Surgical Products Co LLC	Boyne City, MI, United States	Manufacturer	0		0	api.fda.gov
Precision Medical Devices Inc	New Brunswick, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Precision Medical Manufacturing LLC	Wheeling, IL, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0		0	api.fda.gov
Primo Medical Group, Inc	W Bridgewater, MA, United States	Contract manufacturer	0		0	api.fda.gov
ProMed Concepts, LLC	Brighton, TN, United States	Contract manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
R.K. Manufacturing	Danbury, CT, United States	Contract manufacturer	0		0	api.fda.gov
Re:build Tekna, LLC	Kalamazoo, MI, United States	Contract manufacturer	0		0	api.fda.gov
Ready Set Import	Beverly Hills, CA, United States	Specification developer	0		0	api.fda.gov
Revelation Medical Devices, LLC	Auburn, IN, United States	Contract manufacturer, Manufacturer, Remanufacturer	0		0	api.fda.gov
Rhythmlink International, LLC	Columbia, SC, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	api.fda.gov
RSB Spine LLC.	Wooster, OH, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Ranfac Corp.	Avon, MA, United States	Contract manufacturer	0		0	api.fda.gov
Sakura Finetek U.s.a., Inc.	Torrance, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Scanlan International, Inc.	Saint Paul, MN, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	Specification developer	0		0	api.fda.gov
Smith & Nephew Inc.	Mansfield, MA, United States	Manufacturer	0		0	api.fda.gov
Spinal Simplicity, LLC	Overland Park, KS, United States	Manufacturer	0		0	api.fda.gov
Steris Corporation	Montgomery, AL, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
STERIS Corporation	Saint Louis, MO, United States	Manufacturer	0		0	api.fda.gov
Stryker Spine	Allendale, NJ, United States	Complaint file establishment, Manufacturer	0		3	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0		0	api.fda.gov
Surgical Technologies, Inc.	St. Paul, MN, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Synergetics, Inc.	O Fallon, MO, United States	Manufacturer, Specification developer	0		0	api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)	Birmingham, AL, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Sterling Medical Products	Prophetstown, IL, United States	Manufacturer	0		0	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Tedan Surgical Innovations, Inc.	Sugar Land, TX, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Tesa Medical Corporation	San Francisco, CA, United States	Specification developer	0		0	api.fda.gov
TOMZ Corporation	Berlin, CT, United States	Contract manufacturer	0		0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Total Titanium, Inc.	Red Bud, IL, United States	Contract manufacturer, Manufacturer, Remanufacturer	0		0	api.fda.gov
Trademark Plastics Inc.	Riverside, CA, United States	Specification developer	0		0	api.fda.gov
Triangle Manufacturing Co., Inc.	Upper Saddle River, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Trinetics Group	Melbourne, FL, United States	Contract manufacturer	0		0	api.fda.gov
Tegra Medical - Franklin, MA	Franklin, MA, United States	Contract manufacturer	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
Umc Inc.	Monticello, MN, United States	Contract manufacturer	0		0	api.fda.gov
Velocity Orthopedics, Inc.	Rancho Cucamonga, CA, United States	Manufacturer	0		0	api.fda.gov
Vesta	Franklin, WI, United States	Contract manufacturer	0		0	api.fda.gov
Visionare LLC	Fort Myers, FL, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Viant AS&O Holdings, LLC	Indianapolis, IN, United States	Contract manufacturer	0		0	api.fda.gov
Viant Medical, Inc.	Grand Rapids, MI, United States	Contract manufacturer	0		0	api.fda.gov
West Coast Surgical LLC.	Half Moon Bay, CA, United States	Contract manufacturer	0		0	api.fda.gov
West-Conn Tool And Die Inc	Shelton, CT, United States	Contract manufacturer	0		0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	0		0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Welmed, Inc.	Chicago, IL, United States	Specification developer	0		0	api.fda.gov
West Coast Surgical LLC	Houston, TX, United States	Contract manufacturer	0		0	api.fda.gov
Xodus Medical, Inc.	New Kensington, PA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Zien Medical Technologies LLC	Salt Lake City, UT, United States	Manufacturer	0		0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	0		0	api.fda.gov
restor3d, inc.	Durham, NC, United States	Manufacturer	0		0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract 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.