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Data / Medical devices / System, Image Processing, Radiological / United States

FDA-registered makers of System, Image Processing, Radiological in the United States: 235 establishments

235 establishments in the United States are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 162 have a 510(k) clearance or PMA approval on file and 26 have a recall event. FDA data exported November 2, 2026.

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Device
System, Image Processing, Radiological
Product code
LLZ
Country
United States

Makers of System, Image Processing, Radiological in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Canon Medical Informatics, Inc.Minnetonka, MN, United StatesManufacturer, Manufacturer for export, Repackager or relabeler43October 14, 20220100api.fda.gov
Mim Software Inc.Cleveland, OH, United StatesComplaint file establishment, Manufacturer16December 11, 2025020api.fda.gov
Ge HealthcareChicago, IL, United StatesManufacturer, Specification developer15January 8, 20260410api.fda.gov
DeephealthSomerville, MA, United StatesManufacturer13June 5, 2025000api.fda.gov
Merge Healthcare IncorporatedHartland, WI, United StatesManufacturer13April 14, 20250550api.fda.gov
Philips Ultrasound LLCBothell, WA, United StatesComplaint file establishment, Manufacturer, Specification developer12September 24, 2021030api.fda.gov
Philips Ultrasound LLCCambridge, MA, United StatesSpecification developer9September 24, 2021000api.fda.gov
Siemens Medical Solutions Usa, Inc.Hoffman Estates, IL, United StatesManufacturer9July 19, 2019000api.fda.gov
Philips DS North America LLCGainesville, FL, United StatesComplaint file establishment, Manufacturer, Specification developer8June 5, 2025000api.fda.gov
Terarecon, Inc.Fremont, CA, United StatesComplaint file establishment, Manufacturer8August 12, 2022000api.fda.gov
Hologic, Inc.Newark, DE, United StatesComplaint file establishment, Manufacturer7July 11, 2019000api.fda.gov
Ischemaview, Inc.Golden, CO, United StatesManufacturer6August 26, 2025000api.fda.gov
Subtle Medical IncMenlo Park, CA, United StatesManufacturer6May 14, 2026000api.fda.gov
FUJIFILM Healthcare Americas CorporationDurham, NC, United StatesManufacturer5April 25, 2019000api.fda.gov
Anatomage, Inc.Santa Clara, CA, United StatesManufacturer4September 21, 2018000api.fda.gov
Candelis, Inc.Beverly Hills, CA, United StatesManufacturer4July 23, 2026000api.fda.gov
Cortechs Labs, Inc.Cov, KY, United StatesManufacturer4November 19, 2019000api.fda.gov
Echopixel, Inc.San Jose, CA, United StatesManufacturer4July 17, 2020020api.fda.gov
EigenGrass Valley, CA, United StatesManufacturer4November 21, 2018000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesManufacturer4March 6, 2019010api.fda.gov
NDS Surgical Imaging, LLC.Sarasota, FL, United StatesManufacturer, Specification developer4April 28, 2006000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer3April 30, 2020000api.fda.gov
Apryse Software Corp.Charlotte, NC, United StatesComplaint file establishment, Manufacturer3June 25, 2026000api.fda.gov
Broncus Medical IncSan Jose, CA, United StatesManufacturer3February 26, 2014000api.fda.gov
Carestream Dental LLCAtlanta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler3January 16, 2018000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer3August 22, 2023000api.fda.gov
Driving Force Vma, LLCBroussard, LA, United StatesSpecification developer3January 17, 2014000api.fda.gov
Edda Technology, Inc.Princeton, NJ, United StatesComplaint file establishment, Manufacturer3October 31, 2014000api.fda.gov
ImmersiveTouch, Inc.Chicago, IL, United StatesManufacturer3October 16, 2023010api.fda.gov
Intelerad USARaleigh, NC, United StatesComplaint file establishment, Manufacturer, Specification developer3April 2, 2020000api.fda.gov
Konica Minolta Healthcare Americas, IncGarner, NC, United StatesManufacturer3December 16, 2014000api.fda.gov
Novarad Corp.Provo, UT, United StatesManufacturer, Repackager or relabeler3September 21, 2018040api.fda.gov
Orthogrid Systems, IncMidvale, UT, United StatesComplaint file establishment, Manufacturer3February 18, 2021000api.fda.gov
Patterson Dental Supply, Inc.Chatsworth, CA, United StatesManufacturer3November 1, 2022000api.fda.gov
Planet DDSAkron, OH, United StatesManufacturer3November 30, 2018000api.fda.gov
Riverain TechnologiesMiamisburg, OH, United StatesManufacturer3December 27, 2012000api.fda.gov
Siemens Medical Solutions Usa, Inc.Ann Arbor, MI, United StatesManufacturer3May 20, 2022070api.fda.gov
Surgical Theater, Inc.Beachwood, OH, United StatesComplaint file establishment, Manufacturer3July 17, 2020010api.fda.gov
AS Software, LLCEnglewood Cliffs, NJ, United StatesComplaint file establishment, Manufacturer2February 19, 2026010api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer2March 15, 2016000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer2July 25, 2023010api.fda.gov
Carlsmed, Inc.Carlsbad, CA, United StatesManufacturer2December 20, 2024000api.fda.gov
Ceevra, Inc.San Francisco, CA, United StatesManufacturer2July 10, 2018000api.fda.gov
Cleerly, IncDenver, CO, United StatesComplaint file establishment, Manufacturer2July 29, 2026000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer2March 21, 2018000api.fda.gov
Erad, Inc.Greenville, SC, United StatesManufacturer2October 31, 2024000api.fda.gov
Ge Medical Systems, LLCWaukesha, WI, United StatesSpecification developer2January 18, 2013000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer2September 26, 2019000api.fda.gov
Hepatiq, Inc.Ashland, OR, United StatesManufacturer2June 9, 2016000api.fda.gov
Icad Inc.Nashua, NH, United StatesManufacturer2April 5, 2018010api.fda.gov
Imaging Biometrics, LLCElm Grove, WI, United StatesComplaint file establishment, Manufacturer, Specification developer2September 26, 2019000api.fda.gov
Jointvue, LLCKnoxville, TN, United StatesManufacturer2June 25, 2021000api.fda.gov
Lazarus 3D, Inc.Philomath, OR, United StatesManufacturer2May 26, 2023000api.fda.gov
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesManufacturer2August 29, 2019000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer2September 26, 2019000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2September 26, 2019000api.fda.gov
RadmediX, LLCDayton, OH, United StatesManufacturer, Repackager or relabeler2November 23, 2010000api.fda.gov
Scimage, Inc.Los Altos, CA, United StatesManufacturer2January 9, 2008000api.fda.gov
Sentiar, Inc.Saint Louis, MO, United StatesComplaint file establishment, Manufacturer2July 14, 2023000api.fda.gov
Sota Precision Optics, Inc.Orange, CA, United StatesManufacturer2May 4, 2021000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer2December 13, 2018000api.fda.gov
Televere SystemsJanesville, WI, United StatesContract manufacturer, Manufacturer2February 25, 2009000api.fda.gov
Wenzel SpineAustin, TX, United StatesSpecification developer2November 8, 2017040api.fda.gov
Xoran Technologies, LLCAnn Arbor, MI, United StatesComplaint file establishment, Manufacturer, Remanufacturer2May 20, 2021010api.fda.gov
iCRco Inc.Goleta, CA, United StatesManufacturer2January 21, 2014000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer1January 6, 2023000api.fda.gov
Advahealth SolutionsMinneapolis, MN, United StatesComplaint file establishment, Specification developer1January 17, 2024000api.fda.gov
Advanced Image Enhancement, Inc.Fall River, MA, United StatesManufacturer, Specification developer1September 6, 2006000api.fda.gov
Aiq SolutionsMadison, WI, United StatesManufacturer1September 5, 2024000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer1October 29, 2021000api.fda.gov
Apq Health IncLos Angeles, CA, United StatesManufacturer1May 19, 2023000api.fda.gov
Archy Dental, Inc.San Jose, CA, United StatesManufacturer1November 21, 2025000api.fda.gov
Argus Cognitive, Inc.Hanover, NH, United StatesManufacturer1July 24, 2023000api.fda.gov
Ascend Cardiovascular LLCSpringfield, IL, United StatesManufacturer1February 14, 2020000api.fda.gov
Aspyra, LLC.Jacksonville, FL, United StatesManufacturer1March 18, 2010000api.fda.gov
ASTUTE IMAGING IncHanover, NH, United StatesManufacturer1April 23, 2004000api.fda.gov
Atomica Technology, IncAtlanta, GA, United StatesManufacturer1February 2, 2023000api.fda.gov
Avara SoftwareSt Petersburg, FL, United StatesManufacturer1July 10, 2026000api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer1October 29, 2021000api.fda.gov
Blue Sky Bio, LLCLibertyville, IL, United StatesSpecification developer1April 22, 2009000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer1July 24, 2026010api.fda.gov
Brainspec, IncFramingham, MA, United StatesManufacturer1November 14, 2023000api.fda.gov
Brit SystemsWallingford, CT, United StatesManufacturer1March 23, 2009000api.fda.gov
Blue Belt Technologies, Inc.Pittsburgh, PA, United StatesManufacturer1March 11, 2022000api.fda.gov
Cardiovascular Imaging Technologies, LLCKansas City, MO, United StatesManufacturer1April 9, 2008000api.fda.gov
Cardiowise, Inc.Fayetteville, AR, United StatesManufacturer1December 18, 2020000api.fda.gov
Carpl.ai Inc.Cupertino, CA, United StatesManufacturer1March 27, 2024000api.fda.gov
CMR Naviscan CorporationCarlsbad, CA, United StatesManufacturer1September 15, 2011000api.fda.gov
Carestream Health, IncRochester, NY, United StatesManufacturer1March 11, 2010010api.fda.gov
CovidienBoulder, CO, United StatesManufacturer1March 21, 2018000api.fda.gov
Covidien llcPlymouth, MN, United StatesManufacturer, Manufacturer for export1September 16, 2008000api.fda.gov
CurveBeam, LLCHatfield, PA, United StatesManufacturer1August 7, 2018000api.fda.gov
Deeplook Medical, IncScottsdale, AZ, United StatesManufacturer1April 9, 2021000api.fda.gov
DICOM Grid (dba Ambra Health)Raleigh, NC, United StatesComplaint file establishment, Manufacturer1June 7, 2023030api.fda.gov
Dental Imaging Technologies CorporationQuakertown, PA, United StatesComplaint file establishment, Manufacturer1June 22, 2009010api.fda.gov
Elucid BioimagingBoston, MA, United StatesManufacturer1September 18, 2026000api.fda.gov
Epsilon Imaging, Inc.Ann Arbor, MI, United StatesManufacturer1May 27, 2011000api.fda.gov
Ezra Ai, Inc.New York, NY, United StatesManufacturer1April 13, 2023000api.fda.gov
Focalyx TechnologiesHialeah, FL, United StatesManufacturer1June 7, 2017010api.fda.gov
Foresight Imaging, LLCChelmsford, MA, United StatesManufacturer1November 22, 2000000api.fda.gov
Fovia, Inc.Kentfield, CA, United StatesSpecification developer1February 26, 2025000api.fda.gov
Ge Medical Systems, LLCWaukesha, WI, United StatesManufacturer, Specification developer1March 24, 20150410api.fda.gov
GE Medical Systems Ultrasound and Primary Care Diagnostics LLCWauwatosa, WI, United StatesSpecification developer1May 4, 2018000api.fda.gov
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLCWaukesha, WI, United StatesSpecification developer1May 4, 2018000api.fda.gov
Ge Parallel Design, Inc.Phoenix, AZ, United StatesManufacturer1May 4, 2018000api.fda.gov
Globus Medical, Inc.Methuen, MA, United StatesManufacturer1September 19, 2014000api.fda.gov
Good Methods Global Inc.Celebration, FL, United StatesManufacturer1March 13, 2026000api.fda.gov
Guidemia Technologies, LLCBuena Park, CA, United StatesManufacturer1May 31, 2012000api.fda.gov
GlobalMed Holdings, LLCScottsdale, AZ, United StatesComplaint file establishment, Manufacturer1May 7, 2013000api.fda.gov
Henry Schein One, LLCAmes, IA, United StatesManufacturer1July 7, 2015000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesManufacturer1February 2, 2011000api.fda.gov
Hyland Software, Inc.Auburn, CA, United StatesManufacturer1January 28, 2009000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer1February 22, 2019000api.fda.gov
Invia, LLCAnn Arbor, MI, United StatesManufacturer1August 4, 2010000api.fda.gov
Jazz ImagingSan Jose, CA, United StatesManufacturer1November 21, 2024000api.fda.gov
Laborie Medical Technologies Corp.Portsmouth, NH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1May 26, 2005000api.fda.gov
Livemedica, LLCRaleigh, NC, United StatesSpecification developer1February 6, 2026000api.fda.gov
LumedxRaleigh, NC, United StatesComplaint file establishment, Manufacturer1July 5, 2012000api.fda.gov
Marrek, Inc.Sandy, UT, United StatesManufacturer1August 21, 2013000api.fda.gov
Mediview XRCleveland, OH, United StatesManufacturer1July 13, 2023000api.fda.gov
Medivis, Inc.New York, NY, United StatesManufacturer1May 13, 2019000api.fda.gov
Medqia, LLCNorth Waltham, MA, United StatesSpecification developer1August 5, 2011000api.fda.gov
MedstratDowners Grove, IL, United StatesManufacturer1July 14, 2005000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer1March 6, 2019000api.fda.gov
Microstructure Imaging, IncBrooklyn, NY, United StatesSpecification developer1July 17, 2024000api.fda.gov
Multifunctional Imaging LLCMorgan, UT, United StatesManufacturer1February 5, 2018000api.fda.gov
Materialise USA, LLC.Plymouth, MI, United StatesManufacturer1March 21, 2018000api.fda.gov
Myrava, LLCIndianapolis, IN, United StatesManufacturer1May 2, 2023000api.fda.gov
Myrava, LLCWinston Salem, NC, United StatesManufacturer1May 2, 2023000api.fda.gov
Myrava, LLCParma, OH, United StatesManufacturer1May 2, 2023000api.fda.gov
Neosoft, LLCPewaukee, WI, United StatesManufacturer1March 20, 2013000api.fda.gov
O.N. Diagnostics, LLCBerkeley, CA, United StatesManufacturer1August 3, 2018000api.fda.gov
OMNIlife science, Inc.Milpitas, CA, United StatesSpecification developer1January 7, 2025000api.fda.gov
Onepacs, LLCMachesney Park, IL, United StatesManufacturer1October 11, 2018000api.fda.gov
Ortho2Ames, IA, United StatesManufacturer1October 17, 2019000api.fda.gov
Orthopedic Driven Imaging, LLCGainesville, FL, United StatesComplaint file establishment, Specification developer1May 8, 2026000api.fda.gov
OverjetBoston, MA, United StatesManufacturer1May 19, 2021000api.fda.gov
Paxerahealth CorpNewton, MA, United StatesManufacturer1October 31, 2013000api.fda.gov
Polarean, Inc.Durham, NC, United StatesManufacturer1December 23, 2022000api.fda.gov
Radialogica LLCClayton, MO, United StatesManufacturer1October 29, 2010000api.fda.gov
Radiology Information Systems, Inc.Dulles, VA, United StatesManufacturer1November 23, 2010000api.fda.gov
Resoundant, Inc.Rochester, MN, United StatesManufacturer1August 1, 2019000api.fda.gov
Segami CorporationColumbia, MD, United StatesManufacturer1August 31, 2007000api.fda.gov
Siemens Medical Solutions Usa, Inc.Issaquah, WA, United StatesComplaint file establishment, Manufacturer, Specification developer1December 10, 2014000api.fda.gov
Sirona Medical, Inc.San Francisco, CA, United StatesManufacturer1October 22, 2025000api.fda.gov
Smaart Medical Systems, Inc.Dallas, TX, United StatesManufacturer1August 12, 2021000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer1October 17, 2013000api.fda.gov
Sota Cloud CorporationOrange, CA, United StatesManufacturer1May 4, 2021000api.fda.gov
StatRad, LLCSan Diego, CA, United StatesManufacturer1September 15, 2009000api.fda.gov
Thinking Systems Corp.Saint Petersburg, FL, United StatesManufacturer1April 3, 2001000api.fda.gov
Trillium Technology, IncGrass Lake, MI, United StatesManufacturer1October 21, 2008000api.fda.gov
Three Palm SoftwareCarmel, CA, United StatesManufacturer, Manufacturer for export1December 11, 2007000api.fda.gov
TruBridge, Inc.Mobile, AL, United StatesManufacturer1September 30, 2011000api.fda.gov
Ultragreen Data Systems Inc.Long Island City, NY, United StatesComplaint file establishment, Manufacturer1July 17, 2015000api.fda.gov
Unik Orthopedics, IncSan Jose, CA, United StatesManufacturer1May 17, 2013000api.fda.gov
Virtual Radiologic CorporationEdina, MN, United StatesManufacturer1July 18, 2024010api.fda.gov
Vision Chips, Inc.Laguna Niguel, CA, United StatesManufacturer1February 5, 2003000api.fda.gov
Viz.ai, Inc.Cary, NC, United StatesComplaint file establishment, Specification developer1April 20, 2018000api.fda.gov
VoximetryMiddleton, WI, United StatesManufacturer1November 28, 2022000api.fda.gov
Varian Medical Systems, Inc.Atlanta, GA, United StatesManufacturer1February 15, 2018010api.fda.gov
Xironetic R&D CenterOklahoma City, OK, United StatesManufacturer1October 21, 2022000api.fda.gov
Zmicro, Inc.San Diego, CA, United StatesManufacturer1April 12, 2013000api.fda.gov
Advantech CorporationMilpitas, CA, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
Archform, Inc.Santa Clara, CA, United StatesManufacturer0000api.fda.gov
Arterys Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
Arthrex California Technology, IncorporatedSanta Barbara, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Avnet, Inc. (Avnet Logistics)Chandler, AZ, United StatesContract manufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Specification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesSpecification developer0000api.fda.gov
CDB CorporationLeland, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Clear Guide MedicalBaltimore, MD, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Clearadvance, LLCIrvine, CA, United StatesManufacturer0000api.fda.gov
Cuattro Imaging, LLCAvon, CO, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Dymax, Corp.Zelienople, PA, United StatesContract manufacturer, Remanufacturer0000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesContract manufacturer0000api.fda.gov
Enhatch, IncHasbrouck Heights, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
First Source Inc.Rochester, NY, United StatesSpecification developer0000api.fda.gov
Fujifilm Sonosite,inc.Bothell, WA, United StatesManufacturer0010api.fda.gov
GEXPRO, a Division of REXEL USA, Inc.Menomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
Heartflow, Inc.San Francisco, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
HM Product Solutions, Ltd.Hartland, WI, United StatesContract manufacturer0000api.fda.gov
Insight Medical Systems, IncAustin, TX, United StatesSpecification developer0000api.fda.gov
Insight Surgery HoustonHouston, TX, United StatesManufacturer0000api.fda.gov
Insight Surgery NebraskaOmaha, NE, United StatesContract manufacturer0000api.fda.gov
Karl Storz Imaging, Inc.Goleta, CA, United StatesContract manufacturer0000api.fda.gov
KLS Martin Manufacturing, LLCJacksonville, FL, United StatesContract manufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Koios Medical, Inc.New York, NY, United StatesManufacturer0010api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Minxray, Inc.Northbrook, IL, United StatesManufacturer0000api.fda.gov
MedCADPlano, TX, United StatesManufacturer0000api.fda.gov
MetriTrack, Inc.Oak Brook, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
OrthoselectAmerican Fork, UT, United StatesManufacturer0000api.fda.gov
OsteomedAddison, TX, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Prism Clinical Imaging, Inc.Elm Grove, WI, United StatesManufacturer0000api.fda.gov
Philips Ultrasound LLCReedsville, PA, United StatesManufacturer0000api.fda.gov
Progressive AlignersAliso Viejo, CA, United StatesSpecification developer0000api.fda.gov
Progressive Orthodontics USAAliso Viejo, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Q BioSan Carlos, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Softsmile, Inc.Long Island City, NY, United StatesSpecification developer0000api.fda.gov
Sonavex, Inc.Baltimore, MD, United StatesManufacturer0000api.fda.gov
Spectrawave, Inc.Bedford, MA, United StatesManufacturer0000api.fda.gov
Spectrum Assembly Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Spintech, Inc.Bingham Farms, MI, United StatesManufacturer0000api.fda.gov
Standard Imaging, Inc.Middleton, WI, United StatesManufacturer0000api.fda.gov
Steripack Usa (limited) LLCLakeland, FL, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Syntermed, Inc.Atlanta, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Siemens Medical Solutions USA, Inc.Plymouth Meeting, PA, United StatesManufacturer, Specification developer0000api.fda.gov
Spartronics Watertown LLCWatertown, SD, United StatesContract manufacturer0000api.fda.gov
Straumann Manufacturing, Inc.Mansfield, TX, United StatesManufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
TRACKX TECHNOLOGY Inc.Hillsborough, NC, United StatesManufacturer0000api.fda.gov
Trigon America LLCAurora, IL, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Uih Technologies, LLCHouston, TX, United StatesContract manufacturer0000api.fda.gov
Ultraspect Usa, LLCGray, TN, United StatesManufacturer0000api.fda.gov
Vent CreativityNew York, NY, United StatesManufacturer0000api.fda.gov
VanDuzen, Inc. dba MedCADDallas, TX, United StatesManufacturer0000api.fda.gov
Vonco Products, LLCFortville, IN, United StatesContract manufacturer0000api.fda.gov
Wheelhouse MedicalMonroe, NC, United StatesContract manufacturer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
uLab Systems, IncMemphis, TN, United StatesManufacturer0000api.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.