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Data / Medical devices / Continuous Measurement Thermometer / United States

FDA-registered makers of Continuous Measurement Thermometer in the United States: 101 establishments

101 establishments in the United States are registered with the FDA to make Continuous Measurement Thermometer (product code FLL). 52 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Continuous Measurement Thermometer
Product code
FLL
Country
United States

Makers of Continuous Measurement Thermometer in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Kaz USA, Inc., A Helen of Troy CompanyMarlborough, MA, United StatesComplaint file establishment, Manufacturer, Specification developer24April 28, 2020000api.fda.gov
Kaz USA, Inc., A Helen of Troy CompanyOlive Branch, MS, United StatesManufacturer, Repackager or relabeler, Specification developer18April 28, 2020000api.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
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer5December 23, 2020010api.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
Tee-Zed Products, LLCGreensboro, NC, United StatesSpecification developer4October 29, 2018000api.fda.gov
CIRCA Scientific, Inc.Englewood, CO, United StatesManufacturer, Specification developer3May 25, 2023000api.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
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
Fondcircle Inc.Newport Beach, CA, United StatesSpecification developer2October 14, 2023000api.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
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
Solventum Us LLCEagan, MN, United StatesSpecification developer2May 30, 2012000api.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
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
Amplim, LLCSan Francisco, CA, United StatesSpecification developer1October 15, 2013000api.fda.gov
AnriwellRiverside, CA, United StatesRepackager or relabeler, Specification developer1October 14, 2023000api.fda.gov
Bear Down Brands, LLCFullerton, CA, United StatesComplaint file establishment, Specification developer1December 2, 2009000api.fda.gov
Brain Tunnelgenix Technologies CorporationAventura, FL, United StatesSpecification developer1August 17, 2010000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer1January 12, 1982000api.fda.gov
Dorel Juvenile Group, Inc.Columbus, IN, United StatesSpecification developer1December 6, 1996000api.fda.gov
Genesee Biomedical, Inc.Denver, CO, United StatesManufacturer1March 26, 1982000api.fda.gov
Hadleigh Health TechnologiesSausalito, CA, United StatesSpecification developer1August 16, 2023000api.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
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
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
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
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
Tidi Products, LLCNeenah, WI, United StatesManufacturer1October 19, 1998000api.fda.gov
Truer Medical, Inc.Orange, CA, United StatesManufacturer1November 18, 2010000api.fda.gov
Twin River GroupTrenton, NJ, United StatesManufacturer1March 1, 2016000api.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
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesComplaint file establishment, Manufacturer, Specification developer1March 1, 2016010api.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
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Rochester, MN, United StatesContract manufacturer0000api.fda.gov
Biomed Medequip Inc.Rowlett, TX, United StatesContract manufacturer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
CovidienPlainfield, IN, United StatesContract 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
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer0000api.fda.gov
Electronic Development Labs, Inc.Danville, VA, United StatesManufacturer0000api.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
Flash GlobalLockbourne, OH, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.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
Happy HealthAustin, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Infinium Medical, Inc.Largo, FL, United StatesManufacturer0000api.fda.gov
Ipax, Inc.Englewood, CO, United StatesContract manufacturer0000api.fda.gov
J Sterling Industries LLCKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
LifeSignals, Inc.Milpitas, CA, United StatesComplaint file establishment, Specification developer0000api.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
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices, LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Physio-Control, Inc.Redmond, WA, United StatesComplaint file establishment, 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
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Sibel Health Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
Sotera WirelessCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Suntech Medical, Inc.Morrisville, NC, United StatesManufacturer0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer0000api.fda.gov
Toppan Teq LLCHuntley, IL, United StatesContract manufacturer0000api.fda.gov
Vitaldyne, Inc.Cokato, MN, United StatesContract 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 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.