Data / Medical devices / Screwdriver / United States

FDA-registered makers of Screwdriver in the United States: 213 establishments

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

213 establishments in the United States are registered with the FDA to make Screwdriver (product code HXX). 0 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 2, 2026.

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Device: Screwdriver
Product code: HXX
Country: United States

Makers of Screwdriver 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
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
Alva Prototypes Inc	Pottstown, PA, United States	Contract manufacturer, Remanufacturer	0	api.fda.gov
Aptis Medical, LLC.	Glenview, KY, United States	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 - 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, Manufacturer	0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0	api.fda.gov
Able Medical Devices	Marquette, MI, United States	Contract manufacturer, Manufacturer	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
B-One Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer	0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract manufacturer	0	api.fda.gov
Biogennix, LLC	Irvine, CA, United States	Specification developer	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, Repackager or relabeler	2	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Manufacturer	0	api.fda.gov
BioDynamik	Lake Forest, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, 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
Crossroads Extremity Systems LLC	Memphis, TN, United States	Complaint file establishment, 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
Choice Spine LLC	Knoxville, TN, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Complexus Medical	Mishawaka, IN, 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
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
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
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
Ferry Machine Corporation	Oakland, NJ, United States	Contract manufacturer	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
Fortissimo Spine	Knoxville, TN, United States	Specification developer	0	api.fda.gov
Ferry Machine Corporation	Little Ferry, NJ, United States	Contract manufacturer	0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0	api.fda.gov
Genesys Spine	Austin, TX, United States	Manufacturer	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0	api.fda.gov
Gsource, LLC.	Emerson, NJ, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Hammill MFG. Co.	Maumee, OH, United States	Contract manufacturer	0	api.fda.gov
Holmed LLC	Attleboro, MA, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Hoosier, Inc.	Corona, CA, United States	Contract manufacturer	0	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
Iconn Orthopedics, LLC	Birmingham, AL, United States	Complaint file establishment, Manufacturer, Specification developer	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
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
Integra Lifesciences Corporation	Cincinnati, OH, United States	Manufacturer, Repackager or relabeler	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
J&B Precision, Inc.	Cordova, TN, United States	Contract manufacturer	0	api.fda.gov
Janco, Inc.	Rollinsford, NH, United States	Contract manufacturer	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. (Monument)	Monument, CO, United States	Contract manufacturer	0	api.fda.gov
K2M, Inc.	Leesburg, VA, United States	Complaint file establishment, 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
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0	api.fda.gov
LS Investment Ii	Willoughby, OH, United States	Contract manufacturer	0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer, Specification developer	0	api.fda.gov
Mack Molding Company	Arlington, VT, United States	Contract manufacturer	0	api.fda.gov
Mackay Manufacturing, Inc.	Spokane Valley, WA, United States	Contract manufacturer	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
Mclean Medical & Scientific	Saint Paul, MN, 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
Medtech LLC	Millington, TN, United States	Contract 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	2	api.fda.gov
Micro Precision Swiss	Santa Ana, CA, United States	Contract 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	Contract manufacturer	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
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
Nanova Biomaterials Inc	Columbia, MO, United States	Manufacturer, Specification developer	0	api.fda.gov
Nanovis Spine, LLC	Columbia City, IN, United States	Specification developer	0	api.fda.gov
National Presicion Tool Company, Inc. / Roitburg	Fairfield, NJ, United States	Contract manufacturer, 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
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
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
Orthopedic Renovation Technologies LLC	San Antonio, TX, United States	Manufacturer	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
Osteogenics Biomedical, Inc.	Lubbock, TX, United States	Manufacturer	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
Pace Surgical	Malvern, PA, United States	Specification developer	0	api.fda.gov
Pacific Instruments Inc.	Honolulu, HI, 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
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0	api.fda.gov
Precision Medical Technologies	Warsaw, IN, 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 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	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
Quadm Technologies, LLC	Hamilton, NJ, 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
Retrofix Screws, LLC	Salisbury, NC, United States	Specification developer	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	Repackager or relabeler, 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
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	0	api.fda.gov
SIGN Fracture Care International	Richland, WA, 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
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.	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, Specification developer	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	Specification developer	0	api.fda.gov
Summit MFG. And Machining, Inc.	Bremen, IN, United States	Contract manufacturer	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	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer, 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	2	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0	api.fda.gov
Tedan Surgical Innovations, Inc.	Sugar Land, TX, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Theken Companies, LLC	Akron, OH, United States	Specification developer	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
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	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	Complaint file establishment, Specification developer	0	api.fda.gov
Triangle Manufacturing Co., Inc.	Upper Saddle River, NJ, 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
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	Manufacturer for export	0	api.fda.gov
Twin City Edm And MFG Inc	Fridley, MN, 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, Specification developer	1	api.fda.gov
Ulrich Medical Usa, Inc.	Plano, TX, United States	Specification developer	0	api.fda.gov
Unique Surgical, LLC	Fort Wayne, IN, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Unity Tool, Inc.	Osseo, MN, United States	Contract manufacturer	0	api.fda.gov
Universal Punch Corp.	Santa Ana, CA, United States	Contract manufacturer	0	api.fda.gov
Unified Spine, LLC	Westerville, OH, United States	Manufacturer, Specification developer	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	0	api.fda.gov
West-Conn Tool And Die Inc	Shelton, CT, United States	Contract manufacturer	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	1	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Xenix Medical	Orlando, FL, United States	Complaint file establishment, Repackager or relabeler, 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	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.