Data / Medical devices / Bit, Drill / United States

FDA-registered makers of Bit, Drill in the United States: 239 establishments

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

239 establishments in the United States are registered with the FDA to make Bit, Drill (product code HTW). 0 have a 510(k) clearance or PMA approval on file and 15 have a recall event. FDA data exported November 2, 2026.

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Device: Bit, Drill
Product code: HTW
Country: United States

Makers of Bit, Drill 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
Acumed LLC	Hillsboro, OR, United States	Manufacturer, Specification developer	0	api.fda.gov
Aegis Meditec, Inc.	Costa Mesa, CA, United States	Specification developer	0	api.fda.gov
Alden Tool Company, Inc.	Berlin, CT, United States	Contract manufacturer	0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	0	api.fda.gov
Apex Resource Technologies, Inc., PPC Industries, A Spectrum Plastics Group Co.	Pittsfield, MA, United States	Contract manufacturer	0	api.fda.gov
Aptis Medical, LLC.	Glenview, KY, United States	Manufacturer	0	api.fda.gov
Arch Medical Grinding	North Manchester, IN, 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 - 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
Arnold Tuber Industries	Orchard Park, NY, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	1	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0	api.fda.gov
AVALIGN TECHNOLOGIES, Inc.	Fort Wayne, IN, United States	Specification developer	0	api.fda.gov
Able Medical Devices	Marquette, MI, United States	Contract manufacturer	0	api.fda.gov
Acumed LLC -Brookwood Facility	Hillsboro, OR, United States	Manufacturer, Specification developer	0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Artelon	Atl, GA, United States	Manufacturer	0	api.fda.gov
Arthrex Logistic Center	Fort Myers, FL, United States	Manufacturer	0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer	0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0	api.fda.gov
ArthroCare Corporation	Austin, TX, United States	Specification developer	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
B-One Ortho, Corp.	Cedar Knolls, NJ, United States	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	2	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Manufacturer	0	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer	0	api.fda.gov
Boulder Biomed LLC	Boulder, CO, United States	Contract manufacturer, Contract sterilizer	0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0	api.fda.gov
Cadence Device, Inc.	Cranberry Township, PA, 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
Cayenne Medical, Inc.	Scottsdale, AZ, United States	Manufacturer	1	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, Specification developer	0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0	api.fda.gov
Command Medical Products, LLC.	Ormond Beach, FL, United States	Contract manufacturer	0	api.fda.gov
Criterion Tool & Die Inc DBA Criterion Precision Machining	Brookpark, OH, United States	Contract manufacturer	0	api.fda.gov
Demetra, Inc.	Germantown, TN, United States	Specification developer	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
Dunamis Medical LLC	Greenville, AL, United States	Manufacturer, Specification developer	0	api.fda.gov
Eca Medical Instruments	Newbury Park, CA, United States	Contract manufacturer	0	api.fda.gov
Elevation Spine	Monterey, CA, United States	Specification developer	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	0	api.fda.gov
Evergreen Orthopedic Research Lab	Kirkland, WA, United States	Specification developer	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer, Repackager or relabeler	1	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
Exactech Sarasota	Sarasota, FL, United States	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
Flospine LLC	Boca Raton, FL, United States	Manufacturer	0	api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower	Horsham, PA, United States	Specification developer	1	api.fda.gov
Foundation Fusion Solutions, LLC	Tulsa, OK, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
GLW, Inc.	Englewood Cliffs, NJ, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Gramercy Extremity Orthopedics, LLC.	Richardson, TX, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Gsource, LLC.	Emerson, NJ, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer	2	api.fda.gov
Huron Tool & Cutter Grinding	Farmingdale, NY, United States	Contract manufacturer	0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, 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
International Life Sciences	Sandy Springs, GA, United States	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
Janco, Inc.	Rollinsford, NH, United States	Contract manufacturer, Repackager or relabeler	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
K2M, Inc.	Leesburg, VA, United States	Manufacturer, Specification developer	0	api.fda.gov
KLS-Martin L.P.	Jacksonville, FL, United States	Specification developer	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
LAB Medical Manufacturing, Inc.	Billerica, MA, United States	Contract manufacturer	0	api.fda.gov
Lenkbar LLC	Naples, FL, United States	Contract manufacturer	0	api.fda.gov
Life Science Outsourcing, Inc.	Brea, CA, United States	Contract manufacturer, Contract sterilizer	0	api.fda.gov
LinkBio Corp.	Dover, NJ, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Mainstream Medical Devices	Austin, TX, United States	Contract manufacturer	0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	Manufacturer, Specification developer	0	api.fda.gov
Mcginley Orthopaedic Innovations, Inc	Casper, WY, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Mclean Medical & Scientific	Saint Paul, MN, United States	Contract manufacturer	0	api.fda.gov
Medical Component Specialists	Bellingham, MA, United States	Contract manufacturer	0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Complaint file establishment, 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 Puerto Rico Operations Co., Humacao	Humacao, PR, United States	Manufacturer	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer, Repackager or relabeler	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
Microaire Surgical Instruments LLC	Charlottesville, VA, United States	Manufacturer	1	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0	api.fda.gov
Maestro Logistics, LLC	Austin, TX, United States	Contract manufacturer	0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Reprocessor	1	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
Nanova Biomaterials Inc	Columbia, MO, United States	Manufacturer, Specification developer	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
Nuvasive, Inc.	San Diego, CA, United States	Complaint file establishment, Manufacturer, 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
NuVasive Specialized Orthopedics, Inc.	Audubon, PA, United States	Manufacturer	0	api.fda.gov
Nypro Inc (Maple Grove)	Maple Grove, MN, 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
Orbis Medical, LLC	Palmetto Bay, FL, United States	Specification developer	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, Specification developer	0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Orthopedic Generations LLC	Mokena, IL, United States	Specification developer	0	api.fda.gov
Orthopedic Sciences, Inc	Overland Park, KS, United States	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	Manufacturer	0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer	0	api.fda.gov
Omnia Medical	Morgantown, WV, United States	Specification developer	0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0	api.fda.gov
Orthopedic Designs North America, Inc.	Tampa, FL, United States	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, Repackager or relabeler, Specification developer	1	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
Phoenix Instruments, Inc.	Lisle, IL, United States	Contract manufacturer	0	api.fda.gov
Phoenix Medical Products, Inc.	Mountain City, TN, United States	Contract manufacturer	0	api.fda.gov
Pilotis Tech LLC	Brookhaven, GA, United States	Complaint file establishment, Specification developer	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
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0	api.fda.gov
Pioneer Surgical Technology, Inc.	Marquette, MI, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Precision Edge Surgical Products Co LLC	Boyne City, MI, United States	Contract manufacturer	0	api.fda.gov
Precision Edge Surgical Products, LLC	Angola, IN, United States	Contract 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
QTD Plastics	Meadville, PA, United States	Contract manufacturer	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0	api.fda.gov
Red Star Contract Manufacturing Inc.	Larwill, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer	0	api.fda.gov
Renovo, Inc.	Bend, OR, United States	Reprocessor	0	api.fda.gov
Riverpoint Medical LLC	Portland, OR, United States	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
Remington Medical, Inc.	Alpharetta, GA, United States	Contract manufacturer	0	api.fda.gov
Resonetics, LLC	Bethel, CT, United States	Contract manufacturer	0	api.fda.gov
S.S. White Technologies, Inc. / Dba Shukla Medical	St Petersburg, FL, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0	api.fda.gov
Seaspine Orthopedics Corporation	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	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	Complaint file establishment, Specification developer	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
Simpex Medical, Inc.	Fort Mill, SC, United States	Specification developer	0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0	api.fda.gov
Skeletal Dynamics, Inc	Miami, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer, Repackager or relabeler	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	1	api.fda.gov
Spinal Elements, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Spine Wave, Inc.	Shelton, CT, United States	Manufacturer	0	api.fda.gov
Sterramed Inc	Weehawken, NJ, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Stryker Endoscopy	San Jose, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Suretek Medical	Greenville, SC, United States	Reprocessor	0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	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
Sage Product Development, Inc.	Foxborough, MA, 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
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	1	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
The Anspach Effort, Inc.	Palm Bch Gdns, FL, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	2	api.fda.gov
The Orthopaedic Implant Company	Reno, NV, United States	Specification developer	0	api.fda.gov
Theken Companies, LLC	Akron, OH, United States	Specification developer	0	api.fda.gov
Thorn Industries, Dba Tii-Medical	Three Rivers, MA, 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	3	api.fda.gov
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Treace Medical Concepts, Inc.	Ponte Vedra, FL, 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
Trinity Orthopedics, LLC	San Diego, CA, United States	Specification developer	0	api.fda.gov
Tritex Medical Manufacturing LLC	Mount Morris, MI, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Troy Innovative Instruments Co LLC	Middlefield, OH, United States	Contract manufacturer	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 - 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
Titan Spine, a Division of Medtronic	Milwaukee, WI, United States	Manufacturer	0	api.fda.gov
TriPoint Surgical	Columbia City, IN, United States	Contract manufacturer	0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Complaint file establishment, Contract manufacturer, Specification developer	2	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
Tyber Medical	Bethlehem, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
Unique Surgical, LLC	Fort Wayne, IN, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	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
Viant Medical, LLC	Fort Wayne, IN, United States	Complaint file establishment, 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
Xtant Medical Holdings, Inc.	Belgrade, MT, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Zigg Design LLC	Nibley, UT, United States	Contract manufacturer	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	1	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	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.