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

FDA-registered makers of Guide, Surgical, Instrument in the United States: 236 establishments

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

236 establishments in the United States are registered with the FDA to make Guide, Surgical, Instrument (product code FZX). 0 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 3, 2026.

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Device: Guide, Surgical, Instrument
Product code: FZX
Country: United States

Makers of Guide, Surgical, Instrument in the United States

Maker	Location	Role	Recall events	Source
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)	Riviera Beach, FL, United States	Contract manufacturer	0	api.fda.gov
4web Inc.	Frisco, TX, United States	Specification developer	0	api.fda.gov
Accufix Surgical, Inc.	Laramie, WY, United States	Specification developer	0	api.fda.gov
Acme-Monaco Corp.	New Britain, CT, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Ad-Tech Medical Instrument Corp.	Oak Creek, WI, United States	Manufacturer	0	api.fda.gov
Aegis Meditec, Inc.	Costa Mesa, CA, United States	Specification developer	0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	0	api.fda.gov
Aptis Medical, LLC.	Glenview, KY, United States	Manufacturer	0	api.fda.gov
Arc Precision	Isanti, MN, United States	Contract manufacturer	0	api.fda.gov
ARCH - Quakertown	Quakertown, PA, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Elmhurst	Elmhurst, IL, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Olive Branch	Olive Branch, MS, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
ARCH-MedTorque	Kenosha, WI, United States	Contract manufacturer	0	api.fda.gov
Argon Medical Devices Inc.	Athens, TX, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Atricure, Inc.	Mason, OH, United States	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	0	api.fda.gov
Advanced Machine, Inc.	Winchester, TN, United States	Contract manufacturer	0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0	api.fda.gov
B & J Medical LLC	Kendallville, IN, United States	Contract manufacturer	0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract manufacturer	0	api.fda.gov
Biomet Microfixation	Jacksonville, FL, United States	Manufacturer, Repackager or relabeler, Specification developer	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	7	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Manufacturer	0	api.fda.gov
Blustone Synergy, LLC	Pueblo, CO, United States	Specification developer	0	api.fda.gov
Boxspine, LLC	Plymouth, IN, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Bard Access Systems, Inc.	Salt Lake City, UT, United States	Specification developer	0	api.fda.gov
Bausch & Lomb Incorporated	Manchester, MO, United States	Manufacturer	0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer	0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0	api.fda.gov
Camber Spine Technologies	King of Prussia, PA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
CAPTIVA SPINE, Inc.	Jupiter, FL, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Carlsmed, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0	api.fda.gov
Chapman Lake Instrument	Bloomington, IN, United States	Contract manufacturer	0	api.fda.gov
Classic Wire Cut Company, Inc.	Valencia, CA, United States	Contract manufacturer	0	api.fda.gov
Crossroads Extremity Systems LLC	Memphis, TN, United States	Manufacturer	0	api.fda.gov
CTL Medical Corporation	Carrollton, TX, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0	api.fda.gov
Curiteva, Inc.	Tanner, AL, United States	Contract manufacturer	0	api.fda.gov
Cardinal Health	Hazelwood, MO, United States	Specification developer	0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0	api.fda.gov
Cook Incorporated	Bloomington, IN, United States	Complaint file establishment, Manufacturer	1	api.fda.gov
Cook Incorporated	Spencer, IN, United States	Manufacturer	0	api.fda.gov
Covidien	North Haven, CT, United States	Manufacturer	0	api.fda.gov
Criterion Tool & Die Inc DBA Criterion Precision Machining	Brookpark, OH, United States	Contract manufacturer	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	0	api.fda.gov
Diamond Orthopedic	Gastonia, NC, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0	api.fda.gov
DT Medtech LLC	McMinnville, TN, United States	Specification developer	0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	0	api.fda.gov
Eptam Plastics, Ltd	Northfield, NH, United States	Contract manufacturer	0	api.fda.gov
Eptam West LLC	Colorado Springs, CO, United States	Contract manufacturer	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	0	api.fda.gov
Elite Medical, LLC	Bartlett, TN, United States	Contract manufacturer	0	api.fda.gov
Elite Medical, LLC	Florence, AL, United States	Contract manufacturer	0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0	api.fda.gov
Extremity Medical, LLC	Parsippany, NJ, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Fetzer Surgical, LLC	Scottsdale, AZ, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0	api.fda.gov
Flexbar Machine Corp.	Islandia, NY, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Fort Wayne Metals Research Products, LLC	Fort Wayne, IN, United States	Contract manufacturer	0	api.fda.gov
Foundation Fusion Solutions, LLC	Tulsa, OK, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Fischer Surgical Inc.	Imperial, MO, United States	Manufacturer	0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0	api.fda.gov
Gsource, LLC.	Emerson, NJ, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Guidewire Technologies, Inc.	Salem, NH, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Holmed LLC	Attleboro, MA, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Hologic, Inc.	Marlborough, MA, United States	Complaint file establishment, Specification developer	1	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer, Specification developer	0	api.fda.gov
Huron Tool & Cutter Grinding	Farmingdale, NY, United States	Contract manufacturer	0	api.fda.gov
Haven Manufacturing	Ossian, IN, United States	Contract manufacturer	0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0	api.fda.gov
In2bones Usa, LLC	Cordova, TN, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0	api.fda.gov
Innomed, Inc.	Savannah, GA, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Innovative Medical Products, Inc.	Plainville, CT, United States	Specification developer	0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Instrumental Machine & Development, Inc.	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Integrity Systems	Olive Branch, MS, United States	Contract manufacturer	0	api.fda.gov
Intelivation Technologies, LLC	Plymouth Meeting, PA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Instrumed International Inc dba Avalign German Specialty Instruments	Schaumburg, IL, United States	Contract manufacturer, Repackager or relabeler	0	api.fda.gov
Integra LifeSciences Production Corporation	Mansfield, MA, United States	Specification developer	0	api.fda.gov
Jatex, Inc.	Nappanee, IN, United States	Contract manufacturer	0	api.fda.gov
JMG Machine, Inc.	La Mirada, CA, United States	Contract manufacturer	0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, PA, United States	Contract manufacturer	0	api.fda.gov
Jabil Inc. (Elmira)	Horseheads, NY, United States	Contract manufacturer	0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0	api.fda.gov
KLS-Martin L.P.	Jacksonville, FL, United States	Specification developer	0	api.fda.gov
Kmi Imi Group / Dba: Innovative Med, Inc.	Irvine, CA, United States	Manufacturer	0	api.fda.gov
Kalitec Direct LLC DBA Kalitec Medical	Sarasota, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0	api.fda.gov
Life Instrument Corp.	Braintree, MA, United States	Specification developer	0	api.fda.gov
Life Science Outsourcing	Somersworth, NH, United States	Contract manufacturer	0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer	0	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0	api.fda.gov
Manufacturing Technology And Services, LLC	Oxford, AL, United States	Contract manufacturer	0	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
MCMINNVILLE WORKHOLDING COMPANY Inc.	McMinnville, TN, United States	Contract manufacturer	0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Specification developer	0	api.fda.gov
Medshape, Inc.	Atlanta, GA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0	api.fda.gov
Medtronic Perfusion Systems	Minneapolis, MN, United States	Specification developer	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	0	api.fda.gov
Merit Medical Systems, Inc.	South Jordan, UT, United States	Manufacturer	0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Reprocessor	0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0	api.fda.gov
Medartis Inc.	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Reprocessor	0	api.fda.gov
Medtronic Distribution Center	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Mendell	Lakeville, MN, United States	Contract manufacturer	0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0	api.fda.gov
Nucare LLC	Montclair, CA, United States	Specification developer	0	api.fda.gov
Nvision Biomedical Technologies, Inc	San Antonio, TX, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
NanoHive Medical LLC	Woburn, MA, United States	Manufacturer, Specification developer	0	api.fda.gov
Oberg Medical Products Company	Sarver, PA, United States	Contract manufacturer	0	api.fda.gov
Omega Surgical Instruments, Inc.	Flint, MI, United States	Specification developer	0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	1	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Osseus Fusion Systems LLC	Dallas, TX, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Osteomed	Addison, TX, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Oberg Medical - XL Division	Chicago, IL, United States	Contract manufacturer	0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer	0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0	api.fda.gov
Pace Surgical	Malvern, PA, United States	Specification developer	0	api.fda.gov
Pacific Instruments Inc.	Honolulu, HI, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Packaging Compliance Medical, LLC	Kentwood, MI, United States	Contract manufacturer	0	api.fda.gov
Paragon 28	Englewood, CO, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0	api.fda.gov
Parcus Medical, L.L.C.	Sarasota, FL, United States	Manufacturer	0	api.fda.gov
Perryman Company	Houston, PA, United States	Contract manufacturer	0	api.fda.gov
Phoenix Instruments, Inc.	Lisle, IL, United States	Contract manufacturer	0	api.fda.gov
PMC SMART Solutions, LLC	Shelbyville, IN, United States	Contract manufacturer	0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0	api.fda.gov
Princeton Medical Group, Inc.	Franklin, TN, United States	Specification developer	0	api.fda.gov
PTI Engineered Plastics	Macomb, MI, United States	Contract manufacturer	0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0	api.fda.gov
Pioneer Surgical Technology, Inc.	Marquette, MI, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing Facility	N Manchester, IN, United States	Contract manufacturer	0	api.fda.gov
Precision Spine, Inc.	Pearl, MS, United States	Manufacturer	0	api.fda.gov
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0	api.fda.gov
ProMed Concepts, LLC	Brighton, TN, United States	Contract manufacturer	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Red Star Contract Manufacturing Inc.	Larwill, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0	api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)	Alachua, FL, United States	Specification developer	0	api.fda.gov
S.S. White Technologies, Inc. / Dba Shukla Medical	St Petersburg, FL, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Seaspine Orthopedics Corporation	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Seaway Plastics Engineering, LLC	Brooksville, FL, United States	Contract manufacturer	0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	0	api.fda.gov
Si-Bone, Inc.	Santa Clara, CA, United States	Manufacturer	0	api.fda.gov
SIGN Fracture Care International	Richland, WA, United States	Manufacturer	0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0	api.fda.gov
Sky Surgical	Parkville, MO, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	Specification developer	0	api.fda.gov
Smith & Nephew Inc.	Mansfield, MA, United States	Manufacturer, Specification developer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
SPEC Engineering Co.	Hawthorne, CA, United States	Contract manufacturer	0	api.fda.gov
Spine Wave, Inc.	Shelton, CT, United States	Manufacturer	0	api.fda.gov
Steripack Usa (limited) LLC	Lakeland, FL, United States	Contract manufacturer	0	api.fda.gov
Stryker Endoscopy	San Jose, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Stryker Spine	Allendale, NJ, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Summit MFG. And Machining, Inc.	Bremen, IN, United States	Contract manufacturer	0	api.fda.gov
Suncoast Dental, Inc.	Clearwater, FL, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Structure Medical, LLC.	Mooresville, NC, United States	Contract manufacturer	0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	2	api.fda.gov
TACC Inc	Miami Beach, FL, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0	api.fda.gov
Tela Bio, Inc.	Malvern, PA, United States	Manufacturer	0	api.fda.gov
Tetrous, Inc.	Oak Brook, IL, United States	Manufacturer	0	api.fda.gov
The Anspach Effort, Inc.	Palm Bch Gdns, FL, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Theken Companies, LLC	Akron, OH, United States	Specification developer	0	api.fda.gov
Thompson Surgical Instruments, Inc.	Traverse City, MI, United States	Contract manufacturer	0	api.fda.gov
Toby Orthopaedics	Miami, FL, United States	Manufacturer	0	api.fda.gov
TOMZ Corporation	Berlin, CT, United States	Contract manufacturer	0	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Tracer Orthopedics	Oakland, NJ, United States	Contract manufacturer	0	api.fda.gov
Treace Medical Concepts, Inc.	Ponte Vedra, FL, United States	Manufacturer	0	api.fda.gov
Triangle Machine, Inc.	South Bend, IN, United States	Manufacturer	0	api.fda.gov
Triangle Manufacturing Co., Inc.	Upper Saddle River, NJ, United States	Contract manufacturer	0	api.fda.gov
Trice Medical	Malvern, PA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Trigon America LLC	Aurora, IL, United States	Contract manufacturer	0	api.fda.gov
Trimed, Inc.	Santa Clarita, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0	api.fda.gov
Turner Medical Inc.	Athens, AL, United States	Contract manufacturer	0	api.fda.gov
Tegra Medical	Hernando, MS, United States	Contract manufacturer	0	api.fda.gov
Tegra Medical - Franklin, MA	Franklin, MA, United States	Contract manufacturer	0	api.fda.gov
Teleflex LLC (NADC)	Olive Branch, MS, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Teleflex Medical LLC	Morrisville, NC, United States	Complaint file establishment, Specification developer	0	api.fda.gov
The E F PRECISION GROUP	Willow Grove, PA, United States	Contract manufacturer	0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Complaint file establishment, Contract manufacturer, Specification developer	0	api.fda.gov
Unity Tool, Inc.	Osseo, MN, United States	Contract manufacturer	0	api.fda.gov
Unified Spine, LLC	Westerville, OH, United States	Manufacturer, Specification developer	0	api.fda.gov
VGI medical, LLC	Largo, FL, United States	Manufacturer	0	api.fda.gov
Visionare LLC	Fort Myers, FL, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
VanDuzen, Inc. dba MedCAD	Dallas, TX, United States	Manufacturer	0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0	api.fda.gov
Viant Upland, Inc	Upland, CA, United States	Contract manufacturer	0	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	Manufacturer	0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Weco Manufacturing Group-Henrietta	Rochester, NY, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Xtant Medical Holdings, Inc.	Belgrade, MT, United States	Repackager or relabeler, Specification developer	1	api.fda.gov
Zelia Dental Lab LLC	N Brunswick, NJ, United States	Manufacturer	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	4	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	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.