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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device thermometer, electronic, clinical
Regulation Description Clinical electronic thermometer.
Product CodeFLL
Regulation Number 880.2910
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 4
ACTHERM
  SUBSTANTIALLY EQUIVALENT 8
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMPEROR-ELECTRONIC(SZ) CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ARIZANT HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BD
  SUBSTANTIALLY EQUIVALENT 1
BRISTOLINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CADI SCIENTIFIC PTE.LTD
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SMART HEALTH CARE CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
CINCINNATI SUB-ZERO PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
DIABETICA SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 4
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ELMED
  SUBSTANTIALLY EQUIVALENT 1
ENDOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FAMIDOC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL TREASURE INDUSTRIES LTD.
  SUBSTANTIALLY EQUIVALENT 4
GOOD MEDY ENTERPRISE LTD.
  SUBSTANTIALLY EQUIVALENT 1
HARVARD MEDICAL DEVICES LTD.
  SUBSTANTIALLY EQUIVALENT 2
INNOCHIPS TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JAWON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
  1.  K760118  THERMOMETER, DIGITAL FEVER (MEDITEMP)
JXB CO. LTD GUANGZHOU (CHINA)
  SUBSTANTIALLY EQUIVALENT 1
KAZ, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
K-JUMP HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 12
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDPORT, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MESURE TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 8
MICRO IDEA INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MICROLIFE
  SUBSTANTIALLY EQUIVALENT 19
NINGBO HUAHUI MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NORTHEAST MONITORING, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 3
RADIANT INNOVATION, INC.
  SUBSTANTIALLY EQUIVALENT 12
RADIOTHERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT 10
RIO FLEXON TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 2
SABRATEK
  SUBSTANTIALLY EQUIVALENT 1
SAFETY 1ST
  SUBSTANTIALLY EQUIVALENT 1
SALUTRON, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 5
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 3
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 14
TECNIMED S.R.L.
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 2
TRULY INSTRUMENT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
UNIMED
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 3
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WESCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 9
Temperature issue 7
Use of Device Issue 4
Unknown (for use when the device problem is not known) 3
No Information 3
Material perforation 2
Improper or incorrect procedure or method 2
Measurements, inaccurate 1
Display misread 1
Incorrect measurement 1
Probe failure 1
Sensor problems 1
Smoking 1
Excessive cooling 1
Power source issue 1
Total Device Problems 38

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 1 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bestmed, LLC II Dec-16-2015
2 Vital Signs Devices, a GE Healthcare Company II Aug-13-2013
3 Walgreen Company II Jan-11-2012

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