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Data / Medical devices / Continuous Measurement Thermometer

Continuous Measurement Thermometer (FLL): 283 FDA-registered makers in 30 countries

283 establishments in 30 countries are registered with the FDA to make Continuous Measurement Thermometer (product code FLL, Class 2, 21 CFR 880.2910). 152 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 798 510(k) clearances under this code, the latest on June 5, 2026, and lists 14 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
FLL
Device class
2
Regulation
880.2910
Medical specialty
General Hospital

Makers by country

CountryMakers
United States101
China89
Mexico14
Taiwan10
Germany10
Vietnam6
Israel5
United Kingdom5
South Korea5
India4
Netherlands3
Italy3
Malaysia3
Switzerland2
Cambodia2
Thailand2
Finland2
Japan2
France2
Costa Rica2
Philippines2
Turkey1
Austria1
Hong Kong1
Dominican Republic1
Singapore1
Poland1
Bulgaria1
Sweden1
Brazil1

Makers of Continuous Measurement Thermometer

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Microlife Corp.Taipei, TaiwanManufacturer27March 1, 2022000api.fda.gov
Onbo Electronic (shenzhen) Co. Ltd.SHENZHEN Guangdong, ChinaContract manufacturer, Manufacturer27March 1, 2022000api.fda.gov
Kaz USA, Inc., A Helen of Troy CompanyMarlborough, MA, United StatesComplaint file establishment, Manufacturer, Specification developer24April 28, 2020000api.fda.gov
Microlife Intellectual Property GMBHWidnau Sankt Gallen, SwitzerlandSpecification developer23March 1, 2022000api.fda.gov
Kaz USA, Inc., A Helen of Troy CompanyOlive Branch, MS, United StatesManufacturer, Repackager or relabeler, Specification developer18April 28, 2020000api.fda.gov
Avita (wujiang) Co., LtdWujiang City Jiangsu, ChinaManufacturer11July 23, 2018000api.fda.gov
Radiant Innovation Inc.HSINCHU Hsinchu(County), TaiwanSpecification developer11June 5, 2024000api.fda.gov
Sevenground Trading B.V.Dordrecht Zuid-Holland, NetherlandsExporter to the US, Specification developer9January 2, 2019000api.fda.gov
Hangzhou Hua'an Medical & Health Instruments Co.Hangzhou Zhejiang, ChinaExporter to the US, Manufacturer8February 13, 2018000api.fda.gov
Joytech Healthcare Co., Ltd.Hangzhou Zhejiang, ChinaExporter to the US, Manufacturer8July 8, 2020000api.fda.gov
Joytech Healthcare Co.,ltd.Hangzhou Zhejiang, ChinaExporter to the US, Manufacturer8July 8, 2020000api.fda.gov
Masena Invest, BVDordrecht Zuid-Holland, NetherlandsSpecification developer8January 2, 2019000api.fda.gov
Avita CorporationSan-Chung District, New Taipei City, TaiwanManufacturer7July 23, 2018000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer7September 11, 1992000api.fda.gov
R & D Batteries, Inc.Burnsville, MN, United StatesManufacturer7August 18, 1995000api.fda.gov
Hetaida Technology Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer, Manufacturer, Specification developer6February 25, 2021000api.fda.gov
Medisim Ltd.Ness Ziona Central, IsraelComplaint file establishment, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer6October 20, 2015000api.fda.gov
Alicn Medical Shenzhen, IncShenzhen Guangdong, ChinaManufacturer5December 22, 2023000api.fda.gov
Beijing Choice Electronic Technololgy Co., Ltd.Beijing, ChinaExporter to the US, Foreign private label distributor, Manufacturer5January 21, 2022000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer5December 23, 2020010api.fda.gov
Fudakang Industrial Co LtdDongguan Guangdong, ChinaManufacturer5June 7, 2018000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer5September 11, 1992000api.fda.gov
Rens Medcare (cambodia) Co.,ltd.Sihanouk Preah Sihanouk, CambodiaExporter to the US, Manufacturer5November 18, 2019000api.fda.gov
CovidienCiudad Juarez Chihuahua, MexicoManufacturer4August 20, 2024000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer4August 20, 2024000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer4September 20, 2021000api.fda.gov
ONFU electronics Co., LTD.Trang Bom Dong Nai, VietnamContract manufacturer, Manufacturer4June 10, 2009000api.fda.gov
Shenzhen AOJ Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer4June 23, 2025000api.fda.gov
Tee-Zed Products, LLCGreensboro, NC, United StatesSpecification developer4October 29, 2018000api.fda.gov
Avita Corp (thailand) Co., Ltd.Chonburi Chon Buri, ThailandManufacturer3July 23, 2018000api.fda.gov
Acute Ideas Co., Ltd.Taipei, TaiwanExporter to the US, Specification developer3November 28, 2018000api.fda.gov
AirLife Finland OyHelsinki Uusimaa, FinlandSpecification developer3September 29, 2006000api.fda.gov
Bioland Technology Ltd.SHENZHEN Guangdong, ChinaManufacturer3April 5, 2022000api.fda.gov
CIRCA Scientific, Inc.Englewood, CO, United StatesManufacturer, Specification developer3May 25, 2023000api.fda.gov
Cotronic Technology LimitedSHENZHEN, GUANG DONG PROVINCE Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer3May 17, 2013000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer3May 22, 2006000api.fda.gov
Cardinal HealthNorfolk, NE, United StatesManufacturer3May 22, 2006000api.fda.gov
Exergen CorporationWatertown, MA, United StatesManufacturer3July 12, 2001000api.fda.gov
Exergen Corporation Leominster WarehouseLeominster, MA, United StatesManufacturer3July 12, 2001000api.fda.gov
Fiab SPAVicchio Firenze, ItalyExporter to the US, Manufacturer3October 10, 2019000api.fda.gov
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.Danyang Jiangsu, ChinaManufacturer3May 22, 2025000api.fda.gov
Shenzhen Med-Link Electronics Tech Co.,ltdShenzhen Guangdong, ChinaContract manufacturer, Manufacturer3January 8, 2026000api.fda.gov
Shenzhen Jumper Medical Equipment Co.,Ltd.Shenzhen Guangdong, ChinaManufacturer3May 5, 2019000api.fda.gov
Smart Technology Co., Ltd.Foshan Guangdong, ChinaManufacturer, Repackager or relabeler3September 26, 2021000api.fda.gov
Tecnimed S.R.L.VEDANO OLONA Varese, ItalyManufacturer3April 19, 2017000api.fda.gov
Aion BiosystemsLowell, MA, United StatesSpecification developer2March 14, 2025000api.fda.gov
Blue Spark Technologies, Inc.Westlake, OH, United StatesManufacturer, Specification developer2December 3, 2020000api.fda.gov
Cardinal HealthRiverview, FL, United StatesManufacturer2May 22, 2006000api.fda.gov
Dongguan Simzo Electronic Technology Co., Ltd.Dongguan Guangdong, ChinaManufacturer2September 3, 2021000api.fda.gov
Fondcircle Inc.Newport Beach, CA, United StatesSpecification developer2October 14, 2023000api.fda.gov
Golden Smart Home Technology Corp.Hsinchu City Hsinchu(City), TaiwanManufacturer2February 17, 2023000api.fda.gov
Guangdong Genial Technology Co., Ltd.Zhaoqing Guangdong, ChinaManufacturer2October 30, 2024000api.fda.gov
Geon CorporationCHANG HWA HSIEN Changhua, TaiwanManufacturer2June 2, 2010000api.fda.gov
Guangzhou Daxin Health Technology (Dongguan) Co., LtdDongguan City Guangdong, ChinaManufacturer2April 25, 2025000api.fda.gov
Hangzhou Universal Electronic Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer2August 24, 2016000api.fda.gov
Kangfu Medical Equipment FactoryWenzhou Zhejiang, ChinaExporter to the US, Manufacturer2December 10, 2021000api.fda.gov
Kunshan Radiant Innovation Co., Ltd.Jiangsu Province, ChinaContract manufacturer, Manufacturer2January 9, 2017000api.fda.gov
Kinsa Health LLCLehi, UT, United StatesComplaint file establishment, Specification developer2January 17, 2018000api.fda.gov
Med-Linket CorpAlhambra, CA, United StatesManufacturer2August 25, 2020000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesManufacturer, Specification developer2May 20, 2016000api.fda.gov
Metko Medikal ve Tibbi Cihazlar Dis Ticaret Sanayi A.S.Ankara, TurkeyManufacturer2October 25, 2024000api.fda.gov
Ningbo Ranor Medical Science & Technology Co., Ltd.Ningbo Zhejiang, ChinaManufacturer2July 16, 2020000api.fda.gov
Ouachita Contract Manufacturing, LLCMonroe, LA, United StatesRepackager or relabeler, Specification developer2November 28, 2018000api.fda.gov
R.G. Enterprises (u.s.a.), Inc.Madison Heights, MI, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2June 5, 2007000api.fda.gov
Shenzhen Everbest Machinery Industry Co LtdShenzhen Guangdong, ChinaManufacturer2April 16, 2021000api.fda.gov
Shenzhen Finicare Co., Ltd.Shenzhen Guangdong, ChinaManufacturer2February 14, 2025000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer2May 30, 2012000api.fda.gov
Shenzhen Rongfeng Technology Co.,LtdShenzhen Guangdong, ChinaManufacturer2July 21, 2023000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer2May 30, 2012000api.fda.gov
Thermoworks Inc.American Fork, UT, United StatesRepackager or relabeler, Specification developer2June 5, 2024000api.fda.gov
Vega Technologies Inc.Dongguan City Guangdong, ChinaManufacturer2January 14, 2011000api.fda.gov
Vivalnk, Inc.Campbell, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer2December 20, 2022000api.fda.gov
Wellvii IncPalm Beach Gardens, FL, United StatesSpecification developer2February 2, 2024000api.fda.gov
Xiamen Ants Bro Technology Co., Ltd.Xiamen City Fujian, ChinaExporter to the US, Manufacturer2April 22, 2020000api.fda.gov
Amplim, LLCSan Francisco, CA, United StatesSpecification developer1October 15, 2013000api.fda.gov
AnriwellRiverside, CA, United StatesRepackager or relabeler, Specification developer1October 14, 2023000api.fda.gov
Ashitaka Factory Of Terumo Corp.FUJINOMIYA Shizuoka, JapanManufacturer1June 27, 1985000api.fda.gov
Bear Down Brands, LLCFullerton, CA, United StatesComplaint file establishment, Specification developer1December 2, 2009000api.fda.gov
BodycapHerouville Saint-Clair Calvados, FranceManufacturer1June 28, 2023000api.fda.gov
Bailey Instruments LtdManchester, United KingdomManufacturer1November 30, 2017000api.fda.gov
Brain Tunnelgenix Technologies CorporationAventura, FL, United StatesSpecification developer1August 17, 2010000api.fda.gov
Conmo Electronic Company LimitedHuizhou City Guangdong, ChinaManufacturer1February 25, 2021000api.fda.gov
Contec Medical Systems Co., LtdQinhuangdao Hebei, ChinaManufacturer1December 18, 2020000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer1January 12, 1982000api.fda.gov
Dongguan E-Test Technology Co.,ltdDongguan Guangdong, ChinaManufacturer1November 23, 2020000api.fda.gov
Dongguan Jiacom Technology Co., Ltd.Dongguan Guangdong, ChinaManufacturer1July 12, 2018000api.fda.gov
Dorel Juvenile Group, Inc.Columbus, IN, United StatesSpecification developer1December 6, 1996000api.fda.gov
Draegerwerk AG & Co. KGaALUEBECK Schleswig-Holstein, GermanySpecification developer1February 28, 2013000api.fda.gov
Fortechgrp Co., Ltd.Taoyuan city, TaiwanContract manufacturer, Manufacturer1February 8, 2007000api.fda.gov
Genesee Biomedical, Inc.Denver, CO, United StatesManufacturer1March 26, 1982000api.fda.gov
Gri Medical & Electronic Technology Co., Ltd.JIAXING Zhejiang, ChinaManufacturer1August 11, 2011000api.fda.gov
Guangzhou Baoli Hardware & Electronic Co.,ltd.Guangzhou Guangdong, ChinaExporter to the US, Manufacturer, Repackager or relabeler1January 10, 2011000api.fda.gov
Guangdong Prestige Technology Co., Ltd.Dongguan Guangdong, ChinaManufacturer1March 9, 2021000api.fda.gov
Hadleigh Health TechnologiesSausalito, CA, United StatesSpecification developer1August 16, 2023000api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.Mexicali Mexico, MexicoManufacturer1June 11, 2021000api.fda.gov
Kang Ze Industrial Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer1December 16, 2011000api.fda.gov
LivaNova USA, INC.Arvada, CO, United StatesManufacturer1July 19, 1996000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer1June 11, 2021000api.fda.gov
Me Center Of Terumo Corp.FUJINOMIYA Shizuoka, JapanManufacturer1June 27, 1985000api.fda.gov
Mediana Co., Ltd.Wonju-Si, Gangwon-do, South KoreaManufacturer1February 24, 2017000api.fda.gov
Mediusa Inc.Los Angeles, CA, United StatesRemanufacturer, Repackager or relabeler1October 7, 2020000api.fda.gov
Metene LimitedCity of Industry, CA, United StatesSpecification developer1July 23, 2018000api.fda.gov
Ningbo Just Soon Industrial LimitedNingbo Zhejiang, ChinaManufacturer1September 12, 2022000api.fda.gov
Orantech Inc.Shenzhen Guangdong, ChinaExporter to the US, Manufacturer1October 10, 2018000api.fda.gov
Pinghu Sama Medical Packing Co., Ltd.Pinghu Zhejiang, ChinaManufacturer1January 15, 2016000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoManufacturer1September 12, 1979000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1July 19, 1996000api.fda.gov
Philips North America LLCAndover, MA, United StatesRepackager or relabeler, Specification developer1July 19, 1996000api.fda.gov
Qingdao Yasee Medical Device Co.,ltd.QINGDAO Shandong, ChinaManufacturer1September 12, 2022000api.fda.gov
Remedyrepack, Inc.Indiana, PA, United StatesManufacturer, Repackager or relabeler1March 14, 2025000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer1April 22, 2004000api.fda.gov
Sensatronic GMBHWismar Mecklenburg-Western Pomerania, GermanyManufacturer1August 11, 2021000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaExporter to the US, Manufacturer1April 29, 2021000api.fda.gov
Shenzhen Aeon Technology Co.,ltdshenzhen Guangdong, ChinaManufacturer1November 30, 2017000api.fda.gov
Shenzhen Brav Electronic Technologies Co., Ltdshenzhen Guangdong, ChinaManufacturer1March 2, 2018000api.fda.gov
Shenzhen BSX Technology Electronics Co.,ltdShen Zhen Guangdong, ChinaManufacturer1July 23, 2021000api.fda.gov
Shenzhen Changke Connect Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1July 24, 2020000api.fda.gov
Shenzhen Changkun Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1June 17, 2020000api.fda.gov
Shenzhen Juzhong Technology Co.,ltdshenzhen Guangdong, ChinaManufacturer1March 22, 2021000api.fda.gov
Shenzhen Launch Electrical Co., LtdShenzhen Guangdong, ChinaManufacturer1December 10, 2018000api.fda.gov
Shenzhen Medke Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1June 20, 2025000api.fda.gov
Shenzhen Sino-K Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1August 25, 2023000api.fda.gov
Shenzhen Urion Technology Co., Ltd.Shenzhen Guangdong, ChinaExporter to the US, Manufacturer1October 7, 2020000api.fda.gov
Shenzhen Zhengkang Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1March 12, 2021000api.fda.gov
Steadysense GMBHRaaba-Grambach Steiermark, AustriaManufacturer1June 21, 2024000api.fda.gov
Suzhou Melodicare Medical Technology Co., LtdSuzhou Jiangsu, ChinaManufacturer1October 18, 2019000api.fda.gov
Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,LtdShenzhen Guangdong, ChinaManufacturer1August 21, 2014000api.fda.gov
Shenzhen Calibeur Industries Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1October 15, 2019000api.fda.gov
Shenzhen Caremed Medical Technology Co.,Ltd.shenzhen Guangdong, ChinaContract manufacturer, Manufacturer1September 6, 2019000api.fda.gov
Shenzhen Pango Medical Electronics Co., LtdShenzhen Guangdong, ChinaManufacturer1April 3, 2019000api.fda.gov
Solventum US LLCEden Prairie, MN, United StatesManufacturer, Repackager or relabeler1May 30, 2012000api.fda.gov
Starboard Medical, Inc.Irvine, CA, United StatesComplaint file establishment, Specification developer1August 11, 2011000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer1September 12, 1979000api.fda.gov
T&R Biofab Co.,ltd.Siheung-si Gyeonggi, South KoreaManufacturer1December 5, 2023000api.fda.gov
Taiwan Aulisa Medical Devices Technologies, Inc.Taipei City, TaiwanManufacturer1September 27, 2024000api.fda.gov
TE Sensores S. de R.L. de C.VHermosillo Mexico, MexicoComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer1November 21, 1988000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesManufacturer1October 19, 1998000api.fda.gov
Truer Medical, Inc.Orange, CA, United StatesManufacturer1November 18, 2010000api.fda.gov
Truly Instrument LimitedKwai Chung, Hong KongSpecification developer1June 24, 2009000api.fda.gov
Twin River GroupTrenton, NJ, United StatesManufacturer1March 1, 2016000api.fda.gov
Tytocare Ltd.Netanya Central, IsraelManufacturer1March 27, 2019000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1December 13, 1977000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1December 13, 1977000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer1December 13, 1977000api.fda.gov
Tianjin Choice Medical Device Co., Ltd.Tianjin, ChinaContract manufacturer, Exporter to the US1January 21, 2022000api.fda.gov
Unimed Medical Supplies IncShenzhen Guangdong, ChinaManufacturer1May 29, 2012000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesComplaint file establishment, Manufacturer, Specification developer1March 1, 2016010api.fda.gov
Wenzhou Yosun Medical Technology Co., Ltd.Wenzhou Zhejiang, ChinaContract manufacturer, Manufacturer1October 23, 2020000api.fda.gov
Xuzhou Yongkang Electronic Science Technology Co., LtdXuzhou Jiangsu, ChinaManufacturer1July 11, 2018000api.fda.gov
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.Zhongshan Guangdong, ChinaManufacturer1January 15, 2021000api.fda.gov
Zhuhai Yueja Medical Device Technology Co., Ltd.Zhuhai Guangdong, ChinaManufacturer1February 9, 2024000api.fda.gov
Zhuzhou Goldenhot Medical Technology Co.,LtdZhuzhou Hunan, ChinaManufacturer1April 12, 2024000api.fda.gov
3T Medical Systems Inc.Edison, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer0000api.fda.gov
Aidar Health, IncColumbia, MD, United StatesManufacturer, Specification developer0000api.fda.gov
Analog DevicesWilmington, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer0000api.fda.gov
BENCHMARK ELECTRONICS San JorgeTlajomulco de Zuniga Jalisco, MexicoContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Rochester, MN, United StatesContract manufacturer0000api.fda.gov
Bernd Richter GMBHWipperfuerth North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Betacera Inc.Suzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Biobeat Technologies LtdPetakh Tikva Central, IsraelExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Biomed Medequip Inc.Rowlett, TX, United StatesContract manufacturer0000api.fda.gov
Bluepoint Medical GMBH & Co. KGSelmsdorf Mecklenburg-Western Pomerania, GermanyContract manufacturer0000api.fda.gov
Boluo Yuanzhou Dagao Electronics Co. Ltd.P.R. CHINA Xinjiang, ChinaContract manufacturer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AGHAINA San Cristobal, Dominican RepublicManufacturer0000api.fda.gov
Corsano Health B.V.The Hague Zuid-Holland, NetherlandsManufacturer0000api.fda.gov
CPC SolutionsKarmiel Northern, IsraelContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Corsano Health SAPlan-les-Ouates Geneve, SwitzerlandManufacturer0000api.fda.gov
CovidienPlainfield, IN, United StatesContract manufacturer0000api.fda.gov
Current Health LtdEdinburgh Edinburgh, City of, United KingdomSpecification developer0000api.fda.gov
Deroyal Cientifica De Latinoamerica S.R.L.La Aurora, Heredia, Costa RicaContract manufacturer0000api.fda.gov
Dictum Health, Inc.Malibu, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Digicare Biomedical Technology, Inc.Boynton Beach, FL, United StatesManufacturer0000api.fda.gov
Dongguan Rongfeng Medical Co.,ltdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Dreamtech Co., Ltd.Asan-si Chungnam, South KoreaContract manufacturer0000api.fda.gov
Dreamtech Vietnam Co., LtdTu Son Ward Bac Ninh, VietnamContract manufacturer0000api.fda.gov
Dynamic Ems LtdDalgety Bay Fife, United KingdomContract manufacturer0000api.fda.gov
Dongguan CFE Electronic Co., LtdDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Draeger Interservices GmbHLuebeck Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
Easytem Co., LtdSiheung-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer0000api.fda.gov
Electronic Development Labs, Inc.Danville, VA, United StatesManufacturer0000api.fda.gov
Emi (dongguan) Asia LimitedDongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
EMPATICA S.r.l.Milano, ItalyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Ever Ppe IncSealy, TX, United StatesContract manufacturer0000api.fda.gov
East West WisconsinWhitewater, WI, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Famidoc Technology Co., LtdDong Guan Guangdong, ChinaContract manufacturer0000api.fda.gov
Flash GlobalLockbourne, OH, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Flextronics Manufacturing (Singapore) Pte LtdSINGAPORE South East, SingaporeContract manufacturer0000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaManufacturer, Specification developer0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
Guangdong Biolight Meditech Co., LtdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Happy HealthAustin, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Health & Health (group) Co.,ltdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Hochuen Medical Sdn. Bhd.SENAI Johor, MalaysiaContract manufacturer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hochuen Medical Technology Co.,Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Infinium Medical, Inc.Largo, FL, United StatesManufacturer0000api.fda.gov
Intops Co.,ltd.Suwon Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
Inventech Xiamen Co., Ltd.Xiamen Fujian, ChinaContract manufacturer0000api.fda.gov
Ipax, Inc.Englewood, CO, United StatesContract manufacturer0000api.fda.gov
ItekCartago, Costa RicaContract manufacturer0000api.fda.gov
Industrial Vallera de Mexicali, S.A. de C.V. (Terra)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Ionics EMS Inc.Cabuyao City Laguna, PhilippinesContract manufacturer0000api.fda.gov
Ionics EMS, Inc-Plant 2Calamba City Laguna, PhilippinesContract manufacturer0000api.fda.gov
J Sterling Industries LLCKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Jiangyin Sinbon Electronics Co LtdJiangyin Jiangsu, ChinaContract manufacturer0000api.fda.gov
Just Keep Healthy Co., Ltd.Samkkei Munichay District Kampong Speu, CambodiaContract manufacturer0000api.fda.gov
Key Tronic Viet Nam Company LimitedDa Nang, VietnamContract manufacturer0000api.fda.gov
Key-Tech Scotland LtdDunfermline Fife, United KingdomContract manufacturer0000api.fda.gov
Key Tronic CorporationJuarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Key Tronic Juarez, S.A de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Kimball Electronics - Thailand LTDThungsukla Sriracha Chon Buri, ThailandContract manufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Longcheer Meiko Electronics Vietnam Company LimitedHanoi Ha Noi, VietnamContract manufacturer0000api.fda.gov
Luxshare - Ict (nghe An ) LimitedNghe An, VietnamContract manufacturer0000api.fda.gov
LifeSignals India Private LimitedBangalore Karnataka, IndiaContract manufacturer0000api.fda.gov
LifeSignals, Inc.Milpitas, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Maquiladora De Coahuila S De RL De CVCUIDAD ACUNA Coahuila, MexicoContract manufacturer0000api.fda.gov
Medeia Group LtdSofia Sofia-Grad, BulgariaManufacturer0000api.fda.gov
Medwand Solutions, IncRsm, CA, United StatesSpecification developer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Minitube ABTRANGSVIKEN Jamtland, SwedenContract manufacturer0000api.fda.gov
Masimo Medical Technologies (Malaysia) SDN BHDPasir Gudang Johor, MalaysiaComplaint file establishment, Manufacturer0000api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Nonagon Ltd.Caesarea Haifa, IsraelManufacturer0000api.fda.gov
NextPhase Medical Devices, LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Nicolay GMBHNAGOLD Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Osi Systems Pvt Ltd(optoelectronics Division)HYDERABAD Telangana, IndiaContract manufacturer0000api.fda.gov
Physio-Control, Inc.Redmond, WA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pulsion Medical Systems SeAschheim, GermanyContract manufacturer0000api.fda.gov
Philips FranceParis, FranceSpecification developer0000api.fda.gov
Philips Goldway (Shenzhen) Industrial Inc.SHENZHEN Guangdong, ChinaSpecification developer0000api.fda.gov
Philips Medical Systems LtdaVarginha Minas Gerais, BrazilSpecification developer0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Remote Diagnostic Technologies Ltd.FARNBOROUGH Hampshire, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
SecaHamburg, GermanyManufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Shenzhen Comen Medical Instruments Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Creative Industry Co., LtdSHENZHEN Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer, Specification developer0000api.fda.gov
Shenzhen Mondial Technology Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Sibel Health Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
Skanray Technologies LimitedMysore Karnataka, IndiaComplaint file establishment, Manufacturer0000api.fda.gov
Sotera WirelessCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Suntech Medical, Inc.Morrisville, NC, United StatesManufacturer0000api.fda.gov
Supercomal Medical Products, Sdn BhdSUNGAI PETANI Kedah, MalaysiaContract manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Siemens Healthineers AGFORCHHEIM Bavaria, GermanyExporter to the US, Manufacturer0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer0000api.fda.gov
Starboard Medical (Jiangsu) Co. Ltd.Sheyang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Taidoc Technology CorporationNew Taipei City, TaiwanManufacturer0000api.fda.gov
Telstar Vietnam Company LimitedBac Ninh, VietnamContract manufacturer0000api.fda.gov
Toppan Teq LLCHuntley, IL, United StatesContract manufacturer0000api.fda.gov
Tasco Medical Industries Co., Ltd.Bao An District, Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Vitaldyne, Inc.Cokato, MN, United StatesContract manufacturer0000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaContract manufacturer0000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer0000api.fda.gov
Wuhan Strong ElectronicsWuhan Hubei, ChinaContract manufacturer0000api.fda.gov
Zhejiang Hongyu Medical Commodity Co., Ltd.YIWU Zhejiang, ChinaContract manufacturer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov

Updated June 5, 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.