Data / Medical devices / Medical Device Data System

Medical Device Data System (OUG): 261 FDA-registered makers in 29 countries

Name: FDA-registered makers of Medical Device Data System
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

261 establishments in 29 countries are registered with the FDA to make Medical Device Data System (product code OUG, Class 1, 21 CFR 880.6310). 0 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on February 22, 2013, and lists 23 recall events (0 Class I). FDA data exported November 2, 2026.

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Get every maker of this device Makers in the United States Watch this device

Product code: OUG
Device class: 1
Regulation: 880.6310
Medical specialty: General Hospital

Makers by country

Country	Makers
United States	145
Germany	20
Israel	10
United Kingdom	10
China	9
Japan	9
France	7
Sweden	6
Australia	5
Taiwan	5
South Korea	4
Canada	4
Italy	4
Denmark	3
Malaysia	3
Mexico	2
Singapore	2
Belgium	2
Luxembourg	1
Switzerland	1
Poland	1
Vietnam	1
New Zealand	1
Netherlands	1
Ireland	1
Ukraine	1
India	1
Finland	1
South Africa	1

Makers of Medical Device Data System

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	Recall events	Source
Abbott Diabetes Care Inc.	Alameda, CA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Abbott Medical	Sylmar, CA, United States	Manufacturer	0	api.fda.gov
Abiomed, Inc.	Danvers, MA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Ackermann Instrumente GMBH	RIETHEIM, WEILHEIM Baden-Wurttemberg, Germany	Manufacturer	0	api.fda.gov
Active Protective Technologies, Inc.	Conshohocken, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
Actuvi	Dallas, TX, United States	Manufacturer	0	api.fda.gov
Adlink Technology GMBH	Deggendorf Bavaria, Germany	Manufacturer	0	api.fda.gov
Advanced Sterilization Products	Irvine, CA, United States	Specification developer	0	api.fda.gov
AI.BLE Insight Co.,Ltd	CHeonan Chungnam, South Korea	Manufacturer	0	api.fda.gov
Aiq Solutions	Madison, WI, United States	Manufacturer	0	api.fda.gov
Alma Lasers Ltd.	CAESAREA Northern, Israel	Manufacturer	0	api.fda.gov
Alpha Omega Engineering Ltd.	Nof HaGalil Northern, Israel	Manufacturer	0	api.fda.gov
American Portwell Technology, Inc.	Fremont, CA, United States	Manufacturer	0	api.fda.gov
Ametek Lamb Motores De Mexico S. De R.L. De C.V.	Nuevo Laredo Tamaulipas, Mexico	Manufacturer	0	api.fda.gov
Apneicare, LLC	Columbus, OH, United States	Manufacturer, Specification developer	0	api.fda.gov
Aqp One, Inc.	Garden Grove, CA, United States	Manufacturer	0	api.fda.gov
Arspectra Sarl	Foetz Esch-sur-Alzette, Luxembourg	Manufacturer	0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0	api.fda.gov
Artrya	Perth Western Australia, Australia	Complaint file establishment, Manufacturer	0	api.fda.gov
Ascend Cardiovascular LLC	Springfield, IL, United States	Manufacturer	0	api.fda.gov
Aventusoft	Boca Raton, FL, United States	Manufacturer	0	api.fda.gov
Avive Solutions Inc	Brisbane, CA, United States	Manufacturer	0	api.fda.gov
AboCom Systems, Inc.	Zhunan Township Miaoli, Taiwan	Contract manufacturer	0	api.fda.gov
ActiGraph L.L.C.	Pensacola, FL, United States	Manufacturer, Repackager or relabeler, Specification developer	0	api.fda.gov
Agilent Technologies Denmark ApS	GLOSTRUP Hovedstaden, Denmark	Manufacturer	0	api.fda.gov
Agilent Technologies Singapore (International) Pte Ltd.	Singapore North East, Singapore	Specification developer	0	api.fda.gov
AliveCor	Mountain View, CA, United States	Manufacturer	0	api.fda.gov
Arthrex California Technology, Incorporated	Santa Barbara, CA, United States	Contract manufacturer	0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0	api.fda.gov
Avnet, Inc. (Avnet Logistics)	Chandler, AZ, United States	Contract manufacturer	0	api.fda.gov
B. Braun Avitum AG	MELSUNGEN Hesse, Germany	Manufacturer	0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Becton, Dickinson And Company	Irvine, CA, United States	Specification developer	0	api.fda.gov
Behavidence, Inc.	New York, NY, United States	Specification developer	0	api.fda.gov
Benchmark Electronics, Inc.	Winona, MN, United States	Contract manufacturer	0	api.fda.gov
Bien-Air Dental SA	Biel/Bienne Bern, Switzerland	Manufacturer	0	api.fda.gov
Biobrdige Global	San Antonio, TX, United States	Manufacturer	0	api.fda.gov
Biomerieux SA	LA BALME LES GROTTES Isere, France	Manufacturer	1	api.fda.gov
Biomerieux SA	MARCY L ETOILE Rhone, France	Manufacturer	0	api.fda.gov
Boston Brace International, Incorporated	Stoughton, MA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Brainlab Se	Munich Bavaria, Germany	Exporter to the US, Manufacturer	0	api.fda.gov
Bayer Medical Care Inc.	Indianola, PA, United States	Specification developer	0	api.fda.gov
Bayer Medical Care Inc.	Pittsburgh, PA, United States	Manufacturer	0	api.fda.gov
Beacon Biosignals - Cleveland Site	Cleveland, OH, United States	Specification developer	0	api.fda.gov
Beckman Coulter, Inc.	West Sacramento, CA, United States	Manufacturer	0	api.fda.gov
Bongiovi Medical and Health Technologies, LLC	Port Saint Lucie, FL, United States	Manufacturer	0	api.fda.gov
Boston Scientific Corporation	Saint Paul, MN, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Canary Medical Usa LLC	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Care Everywhere LLC	Natick, MA, United States	Manufacturer	0	api.fda.gov
Caregility Corporation	Wall Township, NJ, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Carl Zeiss Vision GMBH	AALEN Baden-Wurttemberg, Germany	Manufacturer	0	api.fda.gov
Ceiba Healthcare Technologies LLC	New York, NY, United States	Manufacturer	0	api.fda.gov
Cellavision AB	LUND Skane, Sweden	Complaint file establishment, Exporter to the US, Manufacturer, Specification developer	0	api.fda.gov
Cloudphysician.ai	Wilmington, DE, United States	Manufacturer	0	api.fda.gov
Cochlear Ltd.	LANE COVE New South Wales, Australia	Manufacturer	0	api.fda.gov
Commwell Research And Development Ltd	kfar saba Central, Israel	Manufacturer	0	api.fda.gov
Computer MD	Fort Lauderdale, FL, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Coroventis Research AB	Uppsala, Sweden	Complaint file establishment, Manufacturer	0	api.fda.gov
Crystalvue Medical Corporation	Taoyuan Dist.,, Taiwan	Manufacturer	0	api.fda.gov
Cureety SAS	Dinan Cotes-d'Armor, France	Manufacturer	0	api.fda.gov
CapsoVision, Inc.	Saratoga, CA, United States	Manufacturer	0	api.fda.gov
Circadia Health, Inc.	El Segundo, CA, United States	Specification developer	0	api.fda.gov
Collaborative Care Diagnostics LLC dba BioMedix	Eagan, MN, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Covidien	Lafayette, CO, United States	Manufacturer, Specification developer	0	api.fda.gov
Creation Technologies Ltd	Burnaby British Columbia, Canada	Contract manufacturer	0	api.fda.gov
DGS Diagnostics Sp. z o.o	Kolbaskowo Zachodniopomorskie, Poland	Contract manufacturer	0	api.fda.gov
DMG Digital Enterprises Se	Hamburg, Germany	Manufacturer	0	api.fda.gov
Dongguan Bao Kang Dian Zi Ke Ji Limited	Dongguan City Guangdong, China	Contract manufacturer	0	api.fda.gov
Dreamed Diabetes Ltd	Petah Tikva Tel Aviv, Israel	Manufacturer	0	api.fda.gov
Dreamtech Co., Ltd.	Asan-si Chungnam, South Korea	Manufacturer	0	api.fda.gov
Dreamtech Vietnam Co., Ltd	Tu Son Ward Bac Ninh, Vietnam	Manufacturer	0	api.fda.gov
Draeger Interservices GmbH	Luebeck Schleswig-Holstein, Germany	Contract manufacturer	0	api.fda.gov
Ebm Technologies, Inc.	Taipei, Taiwan	Manufacturer	0	api.fda.gov
Echosens	Paris, France	Manufacturer	0	api.fda.gov
Edan Instruments, Inc.	Shenzhen Guangdong, China	Contract manufacturer	0	api.fda.gov
Edevice	Merignac Gironde, France	Manufacturer, Specification developer	0	api.fda.gov
Element Science, Inc.	Redwood City, CA, United States	Manufacturer	0	api.fda.gov
Elesta SPA	Calenzano Firenze, Italy	Manufacturer	0	api.fda.gov
Enlitenai Inc	Tracy, CA, United States	Manufacturer	0	api.fda.gov
Equitar Technologies, Inc.	La Jolla, CA, United States	Manufacturer	0	api.fda.gov
ESSILOR International Usine de la Compasserie	Ligny en Barrois Meuse, France	Manufacturer	0	api.fda.gov
Etiometry Inc.	Dedham, MA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Evolve MVMT Pty Ltd	Melbourne Victoria, Australia	Specification developer	0	api.fda.gov
Exocad GMBH	Darmstadt Hesse, Germany	Manufacturer	0	api.fda.gov
Eyeque Corporation	Newark, CA, United States	Manufacturer, Specification developer	0	api.fda.gov
Fenwal, Inc.	Lake Zurich, IL, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Fisher & Paykel Healthcare, Ltd.	EAST TAMAKI Auckland, New Zealand	Complaint file establishment, Manufacturer	0	api.fda.gov
Foreseeson Custom Displays, Inc.	Anaheim, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
Fukuda Denshi Co., Ltd.	Shiroi-shi Chiba, Japan	Manufacturer	0	api.fda.gov
Fukuda Denshi Co., Ltd.	Bunkyo-ku Tokyo, Japan	Specification developer	0	api.fda.gov
Fysicon BV	Oss Noord-Brabant, Netherlands	Manufacturer	0	api.fda.gov
Gome Optical Lens Company Limited	Yonkers, NY, United States	Manufacturer	0	api.fda.gov
Gabriel International Inc.	Honolulu, HI, United States	Manufacturer	0	api.fda.gov
GlobalMed Holdings, LLC	Scottsdale, AZ, United States	Manufacturer	0	api.fda.gov
Glooko Inc	Palo Alto, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Haemonetics Corporation	Boston, MA, United States	Manufacturer	0	api.fda.gov
Healtharc LLC	Hackensack, NJ, United States	Manufacturer	0	api.fda.gov
Healthcare-Id, Inc.	Buffalo Grove, IL, United States	Manufacturer	0	api.fda.gov
Healthwatch	Kfar Saba Central, Israel	Manufacturer	0	api.fda.gov
Heartsine Technologies, Ltd	BELFAST Northern Ireland, United Kingdom	Manufacturer	0	api.fda.gov
Heroic Faith International Ltd.	Taipei City, Taiwan	Manufacturer	0	api.fda.gov
Hill-Rom, Inc.	Raleigh, NC, United States	Manufacturer	0	api.fda.gov
Holoray Inc.	Westmount Quebec, Canada	Complaint file establishment, Manufacturer	0	api.fda.gov
Hopi Medical SA	Rosheim Bas-Rhin, France	Manufacturer	0	api.fda.gov
Horiba Instruments Incorporated	Irvine, CA, United States	Manufacturer	1	api.fda.gov
HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, Japan	Exporter to the US, Manufacturer	0	api.fda.gov
HOYA Corporation PENTAX Lifecare Division	Akishima-shi Tokyo, Japan	Complaint file establishment, Specification developer	0	api.fda.gov
Huma Therapeutics Limited	London England, United Kingdom	Manufacturer	0	api.fda.gov
Henry Schein One, LLC	Ames, IA, United States	Manufacturer	0	api.fda.gov
Hologic, Inc.	Marlborough, MA, United States	Manufacturer	0	api.fda.gov
Hopper Healthcare Ltd	London, United Kingdom	Complaint file establishment, Manufacturer	0	api.fda.gov
HyperMed Technologies Corp.	Grand Forks, ND, United States	Manufacturer, Specification developer	0	api.fda.gov
IBA Dosimetry GmbH	SCHWARZENBRUCK Bavaria, Germany	Manufacturer	0	api.fda.gov
Icu Medical, Inc.	Lake Forest, IL, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Infinium Medical, Inc.	Largo, FL, United States	Manufacturer	0	api.fda.gov
Innovision Medical Technologies, LLC	Baltimore, MD, United States	Specification developer	0	api.fda.gov
Instrumentation Laboratory Co.	Bedford, MA, United States	Manufacturer	0	api.fda.gov
Interacoustics A/S	Middelfart Syddanmark, Denmark	Manufacturer	0	api.fda.gov
Inventis SRL	Padova, Italy	Manufacturer	0	api.fda.gov
Itamar Medical	CAESAREA Haifa, Israel	Manufacturer	0	api.fda.gov
Imalogix LLC	Bryn Mawr, PA, United States	Manufacturer	0	api.fda.gov
InBody Co, Ltd.	Cheonan-si Chungnam, South Korea	Manufacturer	0	api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.	Mexicali Mexico, Mexico	Manufacturer	0	api.fda.gov
Jam-Labs Corp	Fremont, CA, United States	Specification developer	0	api.fda.gov
JWP Manufacturing	Santa Clara, CA, United States	Manufacturer	0	api.fda.gov
Jabil Circuit (Shanghai) Ltd.	Shanghai, China	Contract manufacturer	0	api.fda.gov
Jaeger Medical GmbH	HOECHBERG Bavaria, Germany	Complaint file establishment, Manufacturer	0	api.fda.gov
KESTRA Medical Technologies, Inc.	Kirkland, WA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Key Asic Berhad	PETALING JAYA Selangor, Malaysia	Manufacturer, Specification developer	0	api.fda.gov
Kimball Solutions Jasper, Inc.	Jasper, IN, United States	Contract manufacturer	0	api.fda.gov
Laborie Medical Technologies Corp.	Portsmouth, NH, United States	Manufacturer	0	api.fda.gov
Laitek Inc.	Loveland, CO, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
LifeBot Inc	Chicago, IL, United States	Manufacturer	0	api.fda.gov
M.R.S. SRL	Gazzaniga Bergamo, Italy	Manufacturer	0	api.fda.gov
Masimo Corporation	Irvine, CA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Materialise N.V.	LEUVEN Vlaams Brabant, Belgium	Manufacturer	0	api.fda.gov
Matrix Biologics Inc.	Scottsdale, AZ, United States	Specification developer	0	api.fda.gov
Medical Digital Developers LLC	New Rochelle, NY, United States	Manufacturer	0	api.fda.gov
Medicare Tags Limited T/A Medytrak	Galway Galway(County), Ireland	Complaint file establishment, Manufacturer	0	api.fda.gov
Medimaging Integrated Solution Inc.	Hsinchu Hsinchu(City), Taiwan	Manufacturer	0	api.fda.gov
Medtronic Minimed	Northridge, CA, United States	Complaint file establishment, Manufacturer	1	api.fda.gov
Medtronic Neuromodulation	Minneapolis, MN, United States	Manufacturer	0	api.fda.gov
Medtronic, Inc.	Mounds View, MN, United States	Manufacturer, Specification developer	0	api.fda.gov
Mentaily Innovations Ltd	Or Yehuda Central, Israel	Manufacturer	0	api.fda.gov
Metasystems GMBH	ALTLUSSHEIM Baden-Wurttemberg, Germany	Manufacturer	0	api.fda.gov
Microhealth Inc.	Cambridge, MA, United States	Manufacturer	0	api.fda.gov
Midmark Corporation	Versailles, OH, United States	Manufacturer	0	api.fda.gov
Mim Software Inc.	Cleveland, OH, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Mirada Medical Limited	Oxford (UK) Oxfordshire, United Kingdom	Manufacturer	0	api.fda.gov
Mobilehelp LLC	Philadelphia, PA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Monitair, LLC	Miami, FL, United States	Manufacturer	0	api.fda.gov
Monitored Therapeutics, Inc.	Dublin, OH, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Materialise Ukraine, Rep. office	Kyiv Kyyiv, Misto, Ukraine	Manufacturer	0	api.fda.gov
Medical Informatics Corp.	Houston, TX, United States	Manufacturer	0	api.fda.gov
Medtronic Singapore Operations Pte Ltd	Singapore Central Singapore, Singapore	Manufacturer	0	api.fda.gov
Medtronic, Inc.	Tempe, AZ, United States	Manufacturer	0	api.fda.gov
Mirac, LLC	Lynchburg, OH, United States	Contract manufacturer	0	api.fda.gov
Motive Health, Inc.	Tempe, AZ, United States	Manufacturer, Specification developer	0	api.fda.gov
Murata Vios, Inc.	Woodbury, MN, United States	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	0	api.fda.gov
Murata Vios, Private Limited	Kodihalli, Bangalore Karnataka, India	Manufacturer, Remanufacturer, Repackager or relabeler	0	api.fda.gov
Nanosonics Limited	Macquarie Park New South Wales, Australia	Complaint file establishment, Manufacturer	0	api.fda.gov
Neximatic Inc	North Waltham, MA, United States	Manufacturer	0	api.fda.gov
Nihon Kohden Corp.	SHINJUKU-KU Tokyo, Japan	Specification developer	0	api.fda.gov
Nihon Kohden Tomioka Production Center	TOMIOKA-SHI Gunma, Japan	Manufacturer	0	api.fda.gov
Nonin Medical, Inc.	Plymouth, MN, United States	Manufacturer	0	api.fda.gov
Novarad Corp.	Provo, UT, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center	Tokorozawa Saitama, Japan	Complaint file establishment, Specification developer	0	api.fda.gov
Nobel Biocare c/o Medicim NV	Mechelen Antwerpen, Belgium	Complaint file establishment, Manufacturer	0	api.fda.gov
ONCARE GmbH	Munich Bavaria, Germany	Complaint file establishment, Manufacturer	0	api.fda.gov
Ordinatrum Health	Tustin, CA, United States	Manufacturer	0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	0	api.fda.gov
Orthogrid Systems, Inc	Midvale, UT, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Ositech Communications, Inc.	Guelph Ontario, Canada	Manufacturer	0	api.fda.gov
Osstell AB	GOTEBORG Vastra Gotaland, Sweden	Manufacturer	0	api.fda.gov
Paindrainer AB	Lund Skane, Sweden	Complaint file establishment, Exporter to the US, Manufacturer	0	api.fda.gov
PAINKARE SOLUTIONS inc.	Peachtree City, GA, United States	Manufacturer	0	api.fda.gov
Peerbridge Health, Inc.	Franklin, TN, United States	Manufacturer	0	api.fda.gov
Permobil AB	Sundsvall Vasternorrland, Sweden	Specification developer	0	api.fda.gov
Phantom Laboratory	Greenwich, NY, United States	Manufacturer	0	api.fda.gov
Plexus Corp.	Bathgate West Lothian, United Kingdom	Contract manufacturer	0	api.fda.gov
Potrero Medical, Inc.	Hayward, CA, United States	Manufacturer	0	api.fda.gov
Prolaio Inc.	Chicago, IL, United States	Manufacturer	0	api.fda.gov
Prosomnus Sleep Technologies	Pleasanton, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Pfizer Inc	Parsippany, NJ, United States	Manufacturer for export	0	api.fda.gov
Philips Medizin Systeme Boeblingen GmbH	BOEBLINGEN Baden-Wurttemberg, Germany	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Philips North America LLC	Cambridge, MA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Philips North America LLC	Andover, MA, United States	Specification developer	2	api.fda.gov
Philips North America LLC	Murrysville, PA, United States	Contract manufacturer	0	api.fda.gov
Philips North America LLC	Export, PA, United States	Contract manufacturer	0	api.fda.gov
Polymer Technology Systems	Whitestown, IN, United States	Manufacturer	0	api.fda.gov
Primecare Medical (Suzhou) Co.,Ltd.	Changshu Jiangsu, China	Contract manufacturer	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0	api.fda.gov
Radformation, Inc.	New York, NY, United States	Manufacturer	0	api.fda.gov
Radiometer Medical Aps	BROENSHOEJ Hovedstaden, Denmark	Complaint file establishment, Manufacturer	2	api.fda.gov
Rauland-Borg Corporation	Mount Prospect, IL, United States	Manufacturer	0	api.fda.gov
Rein Medical GMBH	Moenchengladbach North Rhine-Westphalia, Germany	Manufacturer	0	api.fda.gov
Resmed Pty Ltd.	BELLA VISTA New South Wales, Australia	Complaint file establishment, Manufacturer	0	api.fda.gov
Respironics Inc.	Murrysville, PA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Respironics, Inc.	New Kensington, PA, United States	Manufacturer	0	api.fda.gov
Resvent Medical Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0	api.fda.gov
Richard Wolf GMBH	KNITTLINGEN Baden-Wurttemberg, Germany	Manufacturer	0	api.fda.gov
Roche Diagnostics GMBH	MANNHEIM Baden-Wurttemberg, Germany	Manufacturer, Specification developer	0	api.fda.gov
Rocoto Ltd.	Raanana Central, Israel	Manufacturer	0	api.fda.gov
Rokit Healthcare Inc.	Geumcheon-gu Seoul, South Korea	Manufacturer	0	api.fda.gov
RXMX, Inc.	New York, NY, United States	Manufacturer	0	api.fda.gov
RemetricHealth Inc.	Allentown, PA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Rocoto Inc.	Irvine, CA, United States	Manufacturer	0	api.fda.gov
Sanusom Operating Company, Inc.	Brentwood, TN, United States	Manufacturer	0	api.fda.gov
Scican Ltd.	TORONTO Ontario, Canada	Manufacturer	0	api.fda.gov
Seca	Hamburg, Germany	Manufacturer	0	api.fda.gov
Sechrist Industries, Inc.	Anaheim, CA, United States	Manufacturer	0	api.fda.gov
Shanghai Mediworks Precision Instruments Co., Ltd.	Shanghai, China	Manufacturer	0	api.fda.gov
Shenzhen Insighters Medical Technology Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0	api.fda.gov
SHL TeleMedicine International	Tel-Aviv Tel Aviv, Israel	Manufacturer	0	api.fda.gov
Sibel Health Inc.	Chicago, IL, United States	Manufacturer	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
Spaulding Medical, LLC	Menomonee Falls, WI, United States	Manufacturer	0	api.fda.gov
Spectrum Medical Ltd	GLOUCESTER Gloucestershire, United Kingdom	Manufacturer	0	api.fda.gov
Spinal Technology, LLC	West Yarmouth, MA, United States	Specification developer	0	api.fda.gov
Standard Imaging, Inc.	Middleton, WI, United States	Manufacturer	0	api.fda.gov
Stereotaxis, Inc.	Saint Louis, MO, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Stryker Leibinger GMBH & Co. KG	FREIBURG Baden-Wurttemberg, Germany	Manufacturer	0	api.fda.gov
Sysmex Corporation Techno Park	KOBE Hyogo, Japan	Specification developer	0	api.fda.gov
SYSMEX CORPORATION i-SQUARE	Kakogawa Hyogo, Japan	Manufacturer	0	api.fda.gov
Sanmina-SCI Systems (Malaysia) Sdn Bhd	Perai Pulau Pinang, Malaysia	Contract manufacturer	0	api.fda.gov
Shanghai Draeger Medical Instrument Co., Ltd.	Shanghai, China	Specification developer	0	api.fda.gov
Siemens Healthineers AG	ERLANGEN Bavaria, Germany	Contract manufacturer	0	api.fda.gov
Spinal Systems, LLC	Louisville, KY, United States	Specification developer	0	api.fda.gov
Stairway Interactive, LLC	Chicago, IL, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Tecan Cdmo Solutions MH, Corp.	Morgan Hill, CA, United States	Contract manufacturer	0	api.fda.gov
Tecan Cdmo Solutions PN Sdn. Bhd.	Penang Pulau Pinang, Malaysia	Contract manufacturer	0	api.fda.gov
Techsomed	Or Yehuda Central, Israel	Manufacturer	0	api.fda.gov
THD SPA	Correggio Reggio Emilia, Italy	Exporter to the US, Manufacturer	0	api.fda.gov
The Magstim Company Ltd.	Carmarthenshire Wales, United Kingdom	Manufacturer	0	api.fda.gov
Thirdwayv Inc.	Irvine, CA, United States	Manufacturer	0	api.fda.gov
Tidepool Project	Palo Alto, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Tnacity Blue Ocean, Inc.	Memphis, TN, United States	Specification developer	0	api.fda.gov
Terumo BCT, Inc..	Lakewood, CO, United States	Manufacturer	0	api.fda.gov
Theator Inc.	Palo Alto, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Topcon Healthcare Solutions EMEA Oy	OULU Pohjois-Pohjanmaa, Finland	Manufacturer	0	api.fda.gov
Topcon Healthcare, Inc.	Oakland, NJ, United States	Manufacturer	0	api.fda.gov
Unika Health Inc.	Sunnyvale, CA, United States	Specification developer	0	api.fda.gov
Veris Health	Foxborough, MA, United States	Specification developer	0	api.fda.gov
Vision RT Limited	LONDON London, City of, United Kingdom	Complaint file establishment, Specification developer	0	api.fda.gov
Vitazi.ai, Inc.	San Diego, CA, United States	Manufacturer	0	api.fda.gov
Volk Optical Inc.	Mentor, OH, United States	Manufacturer	0	api.fda.gov
Vision RT Ltd	Basingstoke Hampshire, United Kingdom	Manufacturer	0	api.fda.gov
Wanda Connected Health Systems Ltd	Royston, Herts Cambridgeshire, United Kingdom	Manufacturer	0	api.fda.gov
Westwood Precision LLC	Allentown, PA, United States	Contract manufacturer	0	api.fda.gov
Wellspect Healthcare	Molndal Vastra Gotaland, Sweden	Manufacturer	0	api.fda.gov
Xavant Technology (pty) Ltd	Pretoria Gauteng, South Africa	Manufacturer	0	api.fda.gov
Zhejiang Yigao Medical Technology Co., Ltd.	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Zimmer Surgical, Inc.	Dover, OH, United States	Manufacturer	0	api.fda.gov
ZYTO Technologies, Inc.	Lehi, UT, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Zywie, Inc.	Johns Creek, GA, United States	Manufacturer	0	api.fda.gov
eResearchTechnology GmbH	Estenfeld Bavaria, Germany	Complaint file establishment, Manufacturer	0	api.fda.gov
eResearchTechnology, Inc.	Philadelphia, PA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
iHealth Labs, Inc.	Sunnyvale, CA, United States	Manufacturer	0	api.fda.gov
spencer Health Solutions	Morrisville, NC, United States	Specification developer	0	api.fda.gov

Updated February 22, 2013. 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.