TPLC - Total Product Life Cycle

• Device: thermometer, electronic, clinical
• Regulation Description: Clinical electronic thermometer.
• Product Code: FLL
• Regulation Number: 880.2910
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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
JXB CO. LTD GUANGZHOU (CHINA)
	SUBSTANTIALLY EQUIVALENT	1
KAZ, INC.
	SUBSTANTIALLY EQUIVALENT	1
KENDALL
	SUBSTANTIALLY EQUIVALENT	1
K-JUMP HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	11
MALLINCKRODT
	SUBSTANTIALLY EQUIVALENT	2
MEDICAL DATA ELECTRONICS
	SUBSTANTIALLY EQUIVALENT	1
MEDIVANCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDPORT, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	4
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	13
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
Temperature issue	3
Use of Device Issue	2
Unknown (for use when the device problem is not known)	2
Material perforation	2
Excessive cooling	1
Improper or incorrect procedure or method	1
Measurements, inaccurate	1
Probe failure	1
Sensor problems	1
Smoking	1
Total Device Problems	15

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Walgreen Company	II	Jan-11-2012