Data / Medical devices / Retractor / United States

FDA-registered makers of Retractor in the United States: 230 establishments

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

230 establishments in the United States are registered with the FDA to make Retractor (product code GAD). 10 have a 510(k) clearance or PMA approval on file and 12 have a recall event. FDA data exported November 2, 2026.

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Device: Retractor
Product code: GAD
Country: United States

Makers of Retractor in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Coopersurgical, Inc.	Trumbull, CT, United States	Complaint file establishment, Manufacturer, Specification developer	2	April 26, 2005	1	api.fda.gov
Medtronic Distribution Center	Memphis, TN, United States	Manufacturer, Repackager or relabeler	2	February 23, 2005	0	api.fda.gov
Covidien	North Haven, CT, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	1	May 6, 1992	0	api.fda.gov
Covidien	Ponce, PR, United States	Contract manufacturer, Manufacturer	1	May 6, 1992	0	api.fda.gov
Medtronic Perfusion Systems	Minneapolis, MN, United States	Specification developer	1	October 4, 2013	0	api.fda.gov
Medtronic Puerto Rico Operations Co., Humacao	Humacao, PR, United States	Manufacturer	1	February 23, 2005	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer	1	February 23, 2005	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	1	February 23, 2005	0	api.fda.gov
Medtronic Xomed, Inc.	Jacksonville, FL, United States	Manufacturer	1	February 23, 2005	0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer	1	February 23, 2005	0	api.fda.gov
4web Inc.	Frisco, TX, United States	Specification developer	0		0	api.fda.gov
Alira Medical Devices LLC	Rancho Cucamonga, CA, United States	Specification developer	0		0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	0		1	api.fda.gov
Alva Prototypes Inc	Pottstown, PA, United States	Contract manufacturer, Remanufacturer	0		0	api.fda.gov
American Benchmark Machine Works	Olympia, WA, United States	Contract manufacturer	0		0	api.fda.gov
American Medicals	Jacksonville, FL, United States	Specification developer	0		0	api.fda.gov
Apex Resource Technologies, Inc., PPC Industries, A Spectrum Plastics Group Co.	Pittsfield, MA, United States	Contract manufacturer	0		0	api.fda.gov
Applied Medical Technology, Inc.	Brecksville, OH, United States	Manufacturer	0		1	api.fda.gov
ARCH - Quakertown	Quakertown, PA, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Olive Branch	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	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	Complaint file establishment, Specification developer	0		0	api.fda.gov
Automated Medical Products Corp.	Sewaren, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
AVALIGN TECHNOLOGIES, Inc.	Fort Wayne, IN, United States	Specification developer	0		0	api.fda.gov
Able Medical Devices	Marquette, MI, United States	Contract manufacturer	0		0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Astura Medical	Irving, TX, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Autocam Medical	Murfreesboro, TN, 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-One Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer	0		0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract 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
Biomerics	Salt Lake City, UT, United States	Contract manufacturer	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
Biophyx Surgical, Inc.	Edgewater, MD, United States	Specification developer	0		0	api.fda.gov
Black & Black Surgical, Inc.	Tucker, GA, United States	Specification developer	0		0	api.fda.gov
Buxton Biomedical, Inc.	East Hanover, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Bausch & Lomb Incorporated	Manchester, MO, United States	Manufacturer	0		0	api.fda.gov
BihlerMed, LLC	Phillipsburg, NJ, 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.	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Camber Spine Technologies	King of Prussia, PA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
CEA Medical Manufacturing, Inc.	Colorado Springs, CO, United States	Contract manufacturer	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		0	api.fda.gov
Coloplast Manufacturing Us, LLC	Minneapolis, MN, United States	Manufacturer	0		0	api.fda.gov
CTL Medical Corporation	Carrollton, TX, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	api.fda.gov
Curiteva, Inc.	Tanner, AL, United States	Contract manufacturer	0		0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0		0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	0		0	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
DT Medtech LLC	McMinnville, TN, United States	Specification developer	0		0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	0		0	api.fda.gov
Elliquence LLC	Baldwin, NY, United States	Manufacturer	0		0	api.fda.gov
Elmed, Inc.	Glendale Heights, IL, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	0		0	api.fda.gov
Edwards Lifesciences LLC	Draper, UT, United States	Manufacturer	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
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	api.fda.gov
Flexbar Machine Corp.	Islandia, NY, United States	Manufacturer, Specification developer	0		0	api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower	Horsham, PA, United States	Specification developer	0		0	api.fda.gov
Freehold Surgical, Inc.	New Hope, PA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Fischer Surgical Inc.	Imperial, MO, United States	Manufacturer	0		0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0		0	api.fda.gov
Genesee Biomedical, Inc.	Denver, CO, United States	Manufacturer	0		0	api.fda.gov
Geotec, Inc.	Warwick, RI, United States	Contract manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
GLW, Inc.	Englewood Cliffs, NJ, United States	Complaint file establishment, Specification developer	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
H & H Co.	Hayden, ID, United States	Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Harwood Design, Inc.	Bristol, PA, United States	Contract manufacturer	0		0	api.fda.gov
Holger Bumueller LLC	Rutherfordton, NC, United States	Contract manufacturer	0		0	api.fda.gov
Holmed LLC	Attleboro, MA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Specification developer	0		0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0		0	api.fda.gov
INNO Holdings Inc.	Millcreek, UT, United States	Manufacturer	0		0	api.fda.gov
Innomed, Inc.	Savannah, GA, United States	Repackager or relabeler, Specification developer	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
Integra Lifesciences Corporation	Cincinnati, OH, United States	Manufacturer	0		0	api.fda.gov
Integra Neurosciences	Anasco, PR, United States	Manufacturer	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
Intrinsic Therapeutics, Inc.	Woburn, MA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Isomedix Operations, Inc.	Libertyville, IL, United States	Contract sterilizer, Manufacturer for export	0		0	api.fda.gov
Isomedix Operations, Inc.	Temecula, CA, United States	Contract sterilizer, Manufacturer for export	0		0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, PA, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	api.fda.gov
Kapp Surgical, Inc.	Cleveland, OH, United States	Manufacturer	0		0	api.fda.gov
Katalyst Surgical, LLC	Chesterfield, MO, United States	Manufacturer	0		0	api.fda.gov
KLS-Martin L.P.	Jacksonville, FL, United States	Specification developer	0		0	api.fda.gov
Kluge Design Inc.	Rogers, MN, United States	Contract manufacturer	0		0	api.fda.gov
Kronner Prototypes, Inc.	Roseburg, OR, United States	Manufacturer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Life Instrument Corp.	Braintree, MA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Life Spine	Huntley, IL, United States	Specification developer	0		0	api.fda.gov
Lsi Solutions Inc.	Victor, NY, United States	Manufacturer	0		0	api.fda.gov
Lone Star Medical Products	Stafford, TX, United States	Contract manufacturer	0		1	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Mainstream Medical Devices	Austin, TX, United States	Contract manufacturer	0		0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Manufacturer	0		0	api.fda.gov
Mako Surgical Corp.	Weston, FL, United States	Specification developer	0		0	api.fda.gov
Mclean Medical & Scientific	Saint Paul, MN, 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	Specification developer	0		2	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0		0	api.fda.gov
Medtronic Navigation, Inc.	Lafayette, CO, 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	Contract manufacturer	0		0	api.fda.gov
Millennium Surgical Corp	Schaumburg, IL, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract 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
Medartis Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Reprocessor	0		0	api.fda.gov
Medtronic Grand Rapids	Grand Rapids, MI, United States	Manufacturer	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
National Advanced Endoscopy Devices, Inc.	Canoga Park, CA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Northeast Scientific, Inc.	Waterbury, CT, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
NSI-US, Inc.	Colorado Springs, CO, United States	Manufacturer	0		0	api.fda.gov
Nuvasive, Inc.	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
NuVasive Specialized Orthopedics, Inc.	Audubon, PA, United States	Manufacturer	0		0	api.fda.gov
Nypro Inc (Maple Grove)	Maple Grove, MN, United States	Contract manufacturer	0		0	api.fda.gov
OBP Medical Corporation	Lawrence, MA, 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
Ortho Development Corp.	Draper, UT, United States	Manufacturer	0		0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	0		0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	api.fda.gov
Pacific Instruments Inc.	Honolulu, HI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Paragon 28	Englewood, CO, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Perryman Company	Houston, PA, United States	Contract manufacturer	0		0	api.fda.gov
Phoenix Instruments, Inc.	Lisle, IL, United States	Contract manufacturer	0		0	api.fda.gov
Pilotis Tech LLC	Brookhaven, GA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
PMC SMART Solutions, LLC	Shelbyville, IN, United States	Contract manufacturer	0		0	api.fda.gov
Pneumocyte LLC ( Thoracic Innovations - A Dba Of Pneumocyte)	Durham, NC, United States	Specification developer	0		0	api.fda.gov
Post Surgical MFG.	Bay Shore, NY, United States	Contract manufacturer	0		0	api.fda.gov
Premier Dental Products Co.	Plymouth Meeting, PA, United States	Specification developer	0		0	api.fda.gov
Premier Medical	Philadelphia, PA, United States	Contract manufacturer	0		0	api.fda.gov
Princeton Medical Group, Inc.	Franklin, TN, United States	Specification developer	0		0	api.fda.gov
Providence Medical Technology, Inc.	Pleasanton, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	api.fda.gov
Pioneer Surgical Technology, Inc.	Marquette, MI, United States	Contract manufacturer	0		0	api.fda.gov
Precision Medical Manufacturing LLC	Wheeling, IL, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing Facility	N Manchester, IN, United States	Contract manufacturer	0		0	api.fda.gov
Precision Spine, Inc.	Pearl, MS, United States	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
Renovo, Inc.	Bend, OR, United States	Reprocessor	0		0	api.fda.gov
Revelation Medical Devices, LLC	Auburn, IN, United States	Contract manufacturer, Manufacturer, Remanufacturer	0		0	api.fda.gov
Ridge & Crest Company	Monterey Park, CA, United States	Specification developer	0		0	api.fda.gov
Rigicon, Inc.	Ronkonkoma, NY, United States	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
Scanlan International, Inc.	Saint Paul, MN, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Seaspine Orthopedics Corporation	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		1	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	0		0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer, Repackager or relabeler	0		1	api.fda.gov
Spine Wave, Inc.	Shelton, CT, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Spineology Inc.	Saint Paul, MN, United States	Manufacturer	0		0	api.fda.gov
STERIS Corporation	Saint Louis, MO, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Sterramed Inc	Weehawken, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Stryker Endoscopy	San Jose, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Stryker Spine	Allendale, NJ, United States	Complaint file establishment, Manufacturer, Specification developer	0		1	api.fda.gov
Sunoptic Technologies, LLC	Jacksonville, FL, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0		0	api.fda.gov
Swissortho LLC	Providence, RI, United States	Specification developer	0		0	api.fda.gov
Sws-Trimac, Inc.	Saginaw, MI, 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
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	0		2	api.fda.gov
Tacmed Solutions, LLC	Anderson, SC, United States	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
Theken Companies, LLC	Akron, OH, United States	Specification developer	0		0	api.fda.gov
Thompson Mis	Sandown, NH, United States	Specification developer	0		0	api.fda.gov
Thompson Surgical Instruments, Inc.	Traverse City, MI, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Toby Orthopaedics	Miami, FL, United States	Manufacturer	0		0	api.fda.gov
TOMZ Corporation	Berlin, CT, United States	Contract manufacturer	0		0	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	0		0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Treace Medical Concepts, Inc.	Ponte Vedra, FL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Trigon America LLC	Aurora, IL, United States	Contract manufacturer	0		0	api.fda.gov
Trio Medical Manufacturing	Leland, NC, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, 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		1	api.fda.gov
Tullo, LLC	Macomb, MI, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Unity Tool, Inc.	Osseo, MN, United States	Contract manufacturer	0		0	api.fda.gov
Viseon, Inc.	Irvine, CA, United States	Manufacturer	0		0	api.fda.gov
Visionare LLC	Fort Myers, FL, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Vitalcor, Inc.	Westmont, IL, United States	Specification developer	0		0	api.fda.gov
Von Zabern Surgical	Riverside, CA, United States	Contract manufacturer	0		0	api.fda.gov
Viant AS&O Holdings, LLC	Indianapolis, IN, United States	Contract manufacturer	0		0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	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, Repackager or relabeler	0		0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Weco Manufacturing Group-Henrietta	Rochester, NY, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
X40 Tech	La Jolla, CA, United States	Specification developer	0		0	api.fda.gov
Xtant Medical Holdings, Inc.	Belgrade, MT, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	0		0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	0		0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	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.