Thermometer, Clinical Color Change
General Hospital · 21 CFR 880.2900
Recent MDR events
6 adverse event reports on file
- WALNUT WEARABLE SMART THERMOMETERAug 22, 2023InjuryWalnutcares (bearcare) / Bearcare, Inc.MW5144872
- WALNUT THERMOMETERApr 17, 2023InjuryUnkMW5116762
- NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETERJan 6, 2020MalfunctionMedtronic Indicators, Inc.MW5092047
- GERATHERM MERCURY FREE FEVER THERMOMETERApr 17, 2009MalfunctionGeratherm Medical Ag, Germany-exclusively For Rg Medical DiagnosticsMW5010820
- TEMPA-DOTOct 10, 1997MalfunctionPymah Corp.MW4002018
- TEMPA DOT SINGLE USE CLINICAL THERMOMETERMar 26, 19973m HealthcareMW1011039
Event type breakdown
Recalls
2 recall events for this product code
- BearCare, Inc.TerminatedJun 8, 2023
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Nu
There have been reports of skin burns to children wearing the device.
Z-1633-2023 · View FDA record ↗ - Medical Indicators, Inc.TerminatedSep 6, 2013
Tempa DOT Single-Use Clinical Thermometer
TempaDot products may have been mislabeled.
Z-2162-2013 · View FDA record ↗
Registered firms
46 firms currently registered for this product code
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Westrock Converting, Llc
BOLINGBROOK, IL, US
Humetron Co.
Cheongju Chungbuk, KR
Tvp Developments Ltd
Kowloon, HK
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Aero Healthcare
Valley Cottage, NY, US
Nanjing J Sun Healthcare Co.,ltd
Nanjing Jiangsu, CN
Sterigenics Us Llc
Charlotte, NC, US
Rci Hudson De Mexico S. De Rl. De Cv.
Nuevo Laredo Tamaulipas, MX
Tender Corporation
Littleton, NH, US
Gfa Production Xiamen Co., Ltd.
Tong An, Xiamen Fujian, CN
Ningbo Risenmed Technology Co.,ltd.
Ningbo Zhejiang, CN
Solventum Us Llc
San Antonio, TX, US
Shanghai Dynamic Medical Supplies Co., Ltd.
SHANGHAI, CN
Titronics Research & Development
TIFFIN, IA, US
Shenzhen Bairunheng Technology Co., Ltd.
shenzhen Guangdong, CN
Huzhou Junda Industry Co., Ltd.
Anji Zhejiang, CN
Rallinson Corp
Miami, FL, US
Gfa Production Inc
Clearwater, FL, US
Saferlife Products Co.,ltd.
Guangzhou Guangdong, CN
Szy Holdings Llc.
BROOKLYN, NY, US
Coast Imports Llc
Dover, DE, US
P Bhogilal Pvt Ltd
Kolkata West Bengal, IN
American Thermal Instruments, Llc
DAYTON, OH, US
510(k) clearances
14 clearances for this product code
- Brymill Cryogenic CystemsJan 13, 2012
K110305 · CRY-ACTRACKERCAM
- Steri-Aid, Inc.Nov 12, 1996
K963049 · STERI-AID KIT
- Deroyal Critical Care, Div. Deroyal TechnologiesJul 19, 1995
K946046 · DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP
- Kyowa Medex Co., Ltd.Apr 5, 1990
K894893 · POINT CHECKER COLOR STRIP THERMOMETER
- Franklin Diagnostics, Inc.Mar 27, 1989
K884612 · FRANKLIN COLLECTOR(R)
- Pymah Corp.Jun 8, 1988
K881286 · TEMPA-DOT CLINICAL THERMOMETER SHEATH
- Healthcheck Corp.Sep 11, 1986
K863181 · HEALTHCHECK THERM-STRIP
- Joel R.L. Ehren KranzOct 16, 1985
K853515 · PEE WEE THERMOMETERS