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

FDA-registered makers of Tray, Surgical, Instrument in the United States: 289 establishments

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

289 establishments in the United States are registered with the FDA to make Tray, Surgical, Instrument (product code FSM). 9 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 3, 2026.

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Device: Tray, Surgical, Instrument
Product code: FSM
Country: United States

Makers of Tray, Surgical, Instrument in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Class I	Source
STERIS Corporation	Saint Louis, MO, United States	Complaint file establishment, Manufacturer, Specification developer	2	November 22, 1994	0	0	api.fda.gov
Aesculap, Inc.	Center Valley, PA, United States	Complaint file establishment, Specification developer	1	September 12, 1979	1	0	api.fda.gov
Brevet Inc.	Huntington Beach, CA, United States	Manufacturer	1	July 28, 1988	0	0	api.fda.gov
E.M. Adams Co., Inc.	Fort Pierce, FL, United States	Manufacturer	1	January 8, 1982	0	0	api.fda.gov
Gyrus ACMI, Inc.	Brooklyn Park, MN, United States	Complaint file establishment, Specification developer	1	November 22, 1994	0	0	api.fda.gov
Hu-Friedy MFG. Co. LLC	Northbrook, IL, United States	Manufacturer, Specification developer	1	November 8, 1984	0	0	api.fda.gov
STERIS Corporation	Cleveland, OH, United States	Manufacturer, Repackager or relabeler	1	December 12, 1984	0	0	api.fda.gov
Stryker Endoscopy	San Jose, CA, United States	Complaint file establishment, Manufacturer, Specification developer	1	November 22, 1994	0	0	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer, Manufacturer	1	November 22, 1994	0	0	api.fda.gov
3Spine, Inc.	Chattanooga, TN, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
4web Inc.	Frisco, TX, United States	Specification developer	0		0	0	api.fda.gov
A.M. Surgical, Inc.	Nashua, NH, United States	Specification developer	0		0	0	api.fda.gov
Accufix Surgical, Inc.	Laramie, WY, United States	Specification developer	0		0	0	api.fda.gov
Acumed LLC	Hillsboro, OR, United States	Specification developer	0		0	0	api.fda.gov
Advanced Product Solutions Inc.	Dothan, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Advanced Sterilization Products	Irvine, CA, United States	Specification developer	0		0	0	api.fda.gov
Aegis Meditec, Inc.	Costa Mesa, CA, United States	Specification developer	0		0	0	api.fda.gov
Alira Medical Devices LLC	Rancho Cucamonga, CA, United States	Specification developer	0		0	0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
American Medical Endoscopy	Doral, FL, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Arcamed, LLC	Indianapolis, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Arnold Tuber Industries	Orchard Park, NY, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0		0	0	api.fda.gov
Aseptico, Inc.	Woodinville, WA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Augustine Plastics Inc	Somerset, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Aurora Spine, Inc.	Carlsbad, CA, United States	Specification developer	0		0	0	api.fda.gov
AVALIGN TECHNOLOGIES, Inc.	Fort Wayne, IN, United States	Specification developer	0		0	0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Arteriocyte Medical Systems, Inc.	Hopkinton, MA, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Avitus Orthopaedics, Inc	Shelton, CT, United States	Specification developer	0		0	0	api.fda.gov
B & J Medical LLC	Kendallville, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Bahadir Usa LLC	Carneys Point, NJ, United States	Manufacturer	0		0	0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Bicon, LLC	Boston, MA, United States	Specification developer	0		0	0	api.fda.gov
Biomet Microfixation	Jacksonville, FL, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	0		2	0	api.fda.gov
Bioplate, Inc.	Placentia, CA, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Manufacturer	0		0	0	api.fda.gov
Black & Black Surgical, Inc.	Tucker, GA, United States	Specification developer	0		0	0	api.fda.gov
Boedeker Plastics, Inc.	Shiner, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Busse Hospital Disposables	Hauppauge, NY, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		1	0	api.fda.gov
Bausch & Lomb Incorporated	Manchester, MO, United States	Manufacturer	0		0	0	api.fda.gov
Bausch & Lomb Incorporated	Rochester, NY, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Bausch & Lomb Incorporated	Saint Louis, MO, United States	Manufacturer	0		0	0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
C & J Industries, Inc.	Meadville, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Camber Spine Technologies	King of Prussia, PA, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
CAPTIVA SPINE, Inc.	Jupiter, FL, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Cayenne Medical, Inc.	Scottsdale, AZ, United States	Manufacturer	0		0	0	api.fda.gov
Centinel Spine, LLC	West Chester, PA, United States	Specification developer	0		0	0	api.fda.gov
CHS USA Incorporated	Peachtree City, GA, United States	Specification developer	0		0	0	api.fda.gov
Conmed Corporation	Utica, NY, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Coopersurgical, Inc.	Trumbull, CT, United States	Manufacturer	0		0	0	api.fda.gov
CTL Medical Corporation	Carrollton, TX, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Cardinal Health	Hazelwood, MO, United States	Specification developer	0		0	0	api.fda.gov
Cirtec Medical	Rock Hill, SC, United States	Contract manufacturer	0		0	0	api.fda.gov
Clinton Industries, Inc	York, PA, United States	Remanufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
ContainMed, Inc.	Indianapolis, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Cook Incorporated	Bloomington, IN, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Cook Incorporated	Spencer, IN, United States	Manufacturer	0		0	0	api.fda.gov
Criterion Tool & Die Inc DBA Criterion Precision Machining	Brookpark, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Cygnus Medical LLC	Branford, CT, United States	Specification developer	0		0	0	api.fda.gov
Demetra, Inc.	Germantown, TN, United States	Specification developer	0		0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	0		0	0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Deroyal Industries, Inc.	Powell, TN, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Diamond Orthopedic	Gastonia, NC, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Disruptive Medtech, LLC	Laramie, WY, United States	Contract manufacturer, Remanufacturer, Repackager or relabeler	0		0	0	api.fda.gov
DT Medtech LLC	McMinnville, TN, United States	Specification developer	0		0	0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	0		0	0	api.fda.gov
DeRoyal Industries, Inc.	Powell, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Dunamis Medical LLC	Greenville, AL, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Ebner Medical LLC	Orange Park, FL, United States	Specification developer	0		0	0	api.fda.gov
Edwards Lifesciences LLC	Irvine, CA, United States	Manufacturer	0		0	0	api.fda.gov
Elliquence LLC	Baldwin, NY, United States	Manufacturer	0		0	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	0		1	0	api.fda.gov
Essential Dental Systems, Inc.	S Hackensack, NJ, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Estes Design And MFG., Inc.	Cumberland, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	0		0	0	api.fda.gov
EverBrands, Inc.	Garden Grove, CA, United States	Manufacturer	0		0	0	api.fda.gov
Extremity Medical, LLC	Parsippany, NJ, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Fabtech Precision Sheet Metal, LLC	Spokane Valley, WA, United States	Contract manufacturer	0		0	0	api.fda.gov
Fetzer Surgical, LLC	Scottsdale, AZ, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Specification developer	0		0	0	api.fda.gov
Flexbar Machine Corp.	Islandia, NY, United States	Manufacturer	0		0	0	api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower	Horsham, PA, United States	Specification developer	0		0	0	api.fda.gov
Fischer Surgical Inc.	Imperial, MO, United States	Manufacturer	0		0	0	api.fda.gov
G Surgical LLC	Austin, TX, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
General Hospital Supply Corp.	Indian Trail, NC, United States	Specification developer	0		0	0	api.fda.gov
Geotec, Inc.	Warwick, RI, United States	Contract manufacturer	0		0	0	api.fda.gov
Gsource, LLC.	Emerson, NJ, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
H & H Co.	Hayden, ID, United States	Remanufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Harwood Design, Inc.	Bristol, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Healthmark Industries Co., Inc.	Fraser, MI, United States	Manufacturer	0		0	0	api.fda.gov
Holmed LLC	Attleboro, MA, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer, Specification developer	0		2	0	api.fda.gov
Hi-Tech Mold Tool, Inc.	Pittsfield, MA, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0		0	0	api.fda.gov
Iconn Orthopedics, LLC	Birmingham, AL, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
In2bones Usa, LLC	Cordova, TN, United States	Specification developer	0		0	0	api.fda.gov
Innomed, Inc.	Savannah, GA, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Innovative Medical Products, Inc.	Plainville, CT, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Instrumental Machine & Development, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Intelivation Technologies, LLC	Plymouth Meeting, PA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
Integra LifeSciences Production Corporation	Mansfield, MA, United States	Specification developer	0		0	0	api.fda.gov
J & J Instruments, LLC	Northbrook, IL, United States	Specification developer	0		0	0	api.fda.gov
JB Medical Development, LLC Dba/Md3, LLC	Sunrise, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Jewel Precision Sheet Metal & Machining, Inc.	Cedar Grove, NJ, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	0	api.fda.gov
K2M, Inc.	Leesburg, VA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
Katalyst Surgical, LLC	Chesterfield, MO, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Specification developer	0		0	0	api.fda.gov
Katena Products, Inc.	Fenton, MO, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Katena Products, Inc.	Parsippany, NJ, United States	Specification developer	0		0	0	api.fda.gov
Katena Products, Inc.	Randolph, NJ, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Keos	Naples, FL, United States	Specification developer	0		0	0	api.fda.gov
Kinetix Machining	Vista, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
KLS-Martin L.P.	Jacksonville, FL, United States	Specification developer	0		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	0	api.fda.gov
Kerr Corporation	Orange, CA, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Lenox-Maclaren Surgical Corp.	Louisville, CO, United States	Manufacturer	0		0	0	api.fda.gov
Life Instrument Corp.	Braintree, MA, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
LinkBio Corp.	Dover, NJ, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer	0		0	0	api.fda.gov
Mack Molding Company	Arlington, VT, United States	Contract manufacturer	0		0	0	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Mako Surgical Corp.	Weston, FL, United States	Specification developer	0		0	0	api.fda.gov
Mastel Surgical Inc.	Rapid City, SD, United States	Contract manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Mastel Surgical Inc.	Schiller Park, IL, United States	Contract manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Matrix Machining Technologies, Inc.	Memphis, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
Mci Medical Concept Innovation Inc.	Sunrise, FL, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Mclean Medical & Scientific	Saint Paul, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Medical Action Industries, Inc. 306	Arden, NC, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		1	0	api.fda.gov
Medin Technologies, Inc.	Totowa, NJ, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
MEDLINE INDUSTRIES, LP - Laredo	Laredo, TX, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Complaint file establishment, Specification developer	0		2	1	api.fda.gov
Medline Industries, LP - SPT	Waukegan, IL, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Medshape, Inc.	Atlanta, GA, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	0		0	0	api.fda.gov
Medtronic Xomed, Inc.	Jacksonville, FL, United States	Manufacturer	0		0	0	api.fda.gov
Meduloc	Del Mar, CA, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Microaire Surgical Instruments LLC	Charlottesville, VA, United States	Manufacturer	0		0	0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Mizuho America, Inc.	Union City, CA, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Medartis Inc.	Warsaw, IN, United States	Contract manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Medegen Medical Products	Gallaway, TN, United States	Manufacturer	0		0	0	api.fda.gov
Medicraft Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Metal Components LLC	Grand Rapids, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
Nanova Biomaterials Inc	Columbia, MO, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
National Advanced Endoscopy Devices, Inc.	Canoga Park, CA, United States	Manufacturer	0		0	0	api.fda.gov
Nexus Spine, L.L.C.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Nexus Spine, LLC.	Lehi, UT, United States	Specification developer	0		0	0	api.fda.gov
Nordent MFG., Inc.	Elk Grove Village, IL, United States	Manufacturer	0		0	0	api.fda.gov
NanoHive Medical LLC	Woburn, MA, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Ocular Instruments, Inc.	Bellevue, WA, United States	Manufacturer	0		0	0	api.fda.gov
Oculus Surgical Inc	Port St Lucie, FL, United States	Manufacturer	0		0	0	api.fda.gov
Onkos Surgical, Inc.	Parsippany, NJ, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Orbis Medical, LLC	Palmetto Bay, FL, United States	Specification developer	0		0	0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Specification developer	0		0	0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	0		0	0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Orthopedic Sciences, Inc	Overland Park, KS, United States	Specification developer	0		0	0	api.fda.gov
Osseus Fusion Systems LLC	Dallas, TX, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Osteomed	Addison, TX, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Osteoremedies, LLC	Memphis, TN, United States	Specification developer	0		0	0	api.fda.gov
Overture Orthopaedics	Irvine, CA, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Orthopedic Designs North America, Inc.	Tampa, FL, United States	Manufacturer	0		0	0	api.fda.gov
Pace Surgical	Malvern, PA, United States	Specification developer	0		0	0	api.fda.gov
Pacific Instruments Inc.	Honolulu, HI, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon 28	Englewood, CO, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
PCR International Inc.	Laredo, TX, United States	Contract manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Phoenix Instruments, Inc.	Lisle, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
Plastic Sterilizing Tray Corp.	Pittsfield, MA, United States	Manufacturer	0		0	0	api.fda.gov
Practicon, Inc.	Greenville, NC, United States	Specification developer	0		0	0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Princeton Medical Group, Inc.	Franklin, TN, United States	Specification developer	0		0	0	api.fda.gov
Pro-Dex, Inc.	Irvine, CA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Pioneer Surgical Technology, Inc.	Marquette, MI, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Power Dental USA, Inc.	McHenry, IL, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Pro-Dex Inc	Tustin, CA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Ready Set Import	Beverly Hills, CA, United States	Specification developer	0		0	0	api.fda.gov
Responsive Arthroscopy	Minneapolis, MN, United States	Specification developer	0		0	0	api.fda.gov
Retropsoas Technologies, LLC	Frontenac, MO, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Roechling Medical Rochester L.P.	Rochester, NY, United States	Contract manufacturer	0		0	0	api.fda.gov
RSB Spine LLC.	Wooster, OH, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)	Alachua, FL, United States	Specification developer	0		0	0	api.fda.gov
Rogers Foam Corporation	Santa Teresa, NM, United States	Contract manufacturer	0		0	0	api.fda.gov
S.S. White Technologies, Inc. / Dba Shukla Medical	St Petersburg, FL, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Scanlan International, Inc.	Saint Paul, MN, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	0		0	0	api.fda.gov
Si-Bone, Inc.	Santa Clara, CA, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Si-Bone, Inc.	Santa Clara, CA, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
SIGN Fracture Care International	Richland, WA, United States	Manufacturer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	Specification developer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Mansfield, MA, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
SOLUT! Inc.	Lewis Center, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Spinal Alignment Solutions	Wilmington, NC, United States	Specification developer	0		0	0	api.fda.gov
Spinal Elements, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Spinal Simplicity, LLC	Overland Park, KS, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Spine Wave, Inc.	Shelton, CT, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Sterizign Precision Technologies	Brunswick, ME, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Suncoast Dental, Inc.	Clearwater, FL, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Sure Count Surgical, LLC	Los Angeles, CA, United States	Specification developer	0		0	0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0		0	0	api.fda.gov
Swissortho LLC	Providence, RI, United States	Specification developer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Synchronis Medical LLC	Romulus, MI, United States	Manufacturer	0		0	0	api.fda.gov
Synergetics, Inc.	O Fallon, MO, United States	Manufacturer	0		0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Sterling Medical Products	Prophetstown, IL, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Strukmyer Medical	Mesquite, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
SunMed Group Holdings, LLC	Grand Rapids, MI, United States	Specification developer	0		0	0	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Tedan Surgical Innovations, Inc.	Sugar Land, TX, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Tesa Medical Corporation	San Francisco, CA, United States	Specification developer	0		0	0	api.fda.gov
Tetrous, Inc.	Oak Brook, IL, United States	Manufacturer	0		0	0	api.fda.gov
Theken Companies, LLC	Akron, OH, United States	Specification developer	0		0	0	api.fda.gov
Toby Orthopaedics	Miami, FL, United States	Manufacturer	0		0	0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Tracer Orthopedics	Oakland, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Transamerican Technologies International	San Ramon, CA, United States	Manufacturer	0		0	0	api.fda.gov
Treace Medical Concepts, Inc.	Ponte Vedra, FL, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Trice Medical	Malvern, PA, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Trimed, Inc.	Santa Clarita, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
Trimedyne, Inc.	Corona, CA, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Trinity Sterile, Inc.	Salisbury, MD, United States	Manufacturer	0		0	0	api.fda.gov
Turner Medical Inc.	Athens, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
TechNH, INC.	Merrimack, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Teleflex LLC (NADC)	Olive Branch, MS, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Teleflex Medical LLC	Morrisville, NC, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
The Vollrath Company LLC	Kiel, WI, United States	Manufacturer	0		0	0	api.fda.gov
Trifecta Medical, LLC	Plainfield, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Umc Inc.	Monticello, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	0		0	0	api.fda.gov
Versah LLC	Jackson, MI, United States	Manufacturer	0		0	0	api.fda.gov
Versah, LLC	Jackson, MI, United States	Manufacturer	0		0	0	api.fda.gov
Vitalitec Int'l., Inc.	Plymouth, MA, United States	Specification developer	0		0	0	api.fda.gov
Vollrath Company LLC, The	Sheboygan, WI, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Vorzeigen	Connersville, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Vericel Corporation	Cambridge, MA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
Viant AS&O Holdings, LLC	Indianapolis, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	Manufacturer	0		0	0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
West Coast Surgical LLC.	Half Moon Bay, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	0		0	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Specification developer	0		0	0	api.fda.gov
West Coast Surgical LLC	Houston, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Xenix Medical	Orlando, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Xodus Medical, Inc.	New Kensington, PA, United States	Manufacturer	0		0	0	api.fda.gov
Zapalign LLC	Fort Lauderdale, FL, United States	Manufacturer for export, Repackager or relabeler	0		0	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	0		2	0	api.fda.gov
Zirc Dental Products, Inc.	Buffalo, MN, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
ZimVie US Corp LLC	Palm Beach Gardens, FL, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	0		0	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	0	api.fda.gov

Updated November 3, 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.