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Panels › General Hospital › Product code FLL · Class 2

Continuous Measurement Thermometer

Regulation 880.2910

2510(k)s in 12 months (798 all time)
1recalls in 12 months (19 all time)
18recalls that name a 510(k)
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Top companies in FLL

Company510(k)sRecalls
Microlife Intellectual Property GmbH200
R & D Batteries, Inc.190
Taidoc Technology Corporation160
Radiant Innovation, Inc.150
K-Jump Health Co., Ltd.140
Mesure Technology130
Avita Corporation110
Mon-A-Therm, Inc.110
Electromedics, Inc.100
Respiratory Support Products, Inc.100
DateFirm and productCodeLinked 510(k)
Sep 22, 2026DeRoyal Industries Inc
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Open, Classified		 FLLK925792
Oct 23, 2025Baxter Healthcare Corporation
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
Open, Classified		 FLLK030580
Jul 11, 2024Baxter Healthcare Corporation
Braun Thermoscan PRO 6000 Ear Thermometer
Open, Classified		 FLLK152748
Jul 20, 2021Welch Allyn Inc
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adul
Open, Classified		 FLLK152748
Oct 28, 2019Cardinal Health 200, LLC
Genius 2 Tympanic Thermometer Private Label Item Code: 3069
Terminated		 FLLK060649
Oct 28, 2019Cardinal Health 200, LLC
Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063
Terminated		 FLLK060649
Oct 28, 2019Cardinal Health 200, LLC
Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
Terminated		 FLLK060649
Oct 28, 2019Cardinal Health 200, LLC
Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
Terminated		 FLLK060649
Oct 28, 2019Cardinal Health 200, LLC
Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000
Terminated		 FLLK060649
Feb 22, 2018Philips Consumer Lifestyle
Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)
Terminated		 FLLK100488
Oct 17, 20173M Company - Health Care Business
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
Terminated		 FLLK120412
Mar 13, 2017Measurement Specialties Inc
Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to contin
Open, Classified		 FLLK962070
Dec 16, 2015Bestmed, LLC
Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Devic
Terminated		 FLLK103617
Aug 13, 2013Vital Signs Devices, a GE Healthcare Company
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsig
Terminated		 FLLK051873
Jan 11, 2012Walgreen Company
Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model WIC551226
Terminated		 FLLK041516
Apr 18, 2006Smiths Medical ASD, Inc.
TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor
Terminated		 FLLK864195
Apr 18, 2006Smiths Medical ASD, Inc.
STS-400 Level1 Skin Temperature Sensor with 400 Series Thermistor
Terminated		 FLLK864195
Feb 4, 2006Omron Healthcare, Inc.
Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an accurate patient temperature measurement in 4-6 seconds typically in the oral,
Terminated		 FLLK983887
Jan 16, 2004Welch Allyn Inc
Sure Temp Plus Model 690/692 Oral Temperature Probes
Terminated		 FLLNone listed

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