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AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.

FDA Recall
Terminated ·AirStrip Technologies, Inc.·Product code LQK·August 4, 2016

Home Uterine Activity Monitor

FDA classification
FDA Class 2 ·Home Uterine Activity Monitor

HU-FRIEDY

FDA UDI
HU-FRIEDY MFG. CO., LLC·10889950079536·LIGATURE DIRECTORS- DR. KNIGHT HANDEL#6

LIK SANG OPTICAL FACTORY

FDA registration
LIK SANG OPTICAL FACTORY·2 products·🇭🇰 Hong Kong

ACETAMINOPHEN L3K

FDA UDI
SEKISUI DIAGNOSTICS, LLC·00628063400027·

Ammonia L3K

FDA UDI
SEKISUI DIAGNOSTICS, LLC·00628063400010·

UREA-L3K

FDA UDI
SEKISUI DIAGNOSTICS, LLC·00628063400966·

ACETAMINOPHEN L3K

FDA UDI
SEKISUI DIAGNOSTICS, LLC·00628063400034·

UREA-L3K

FDA UDI
SEKISUI DIAGNOSTICS, LLC·00628063400973·

RadiForce®

FDA UDI
EIZO CORPORATION·04995047059752·2MP Multitouch Color LCD Monitor

RadiForce®

FDA UDI
EIZO CORPORATION·04995047050919·2MP Multitouch Color LCD Monitor

Guangdong Shunde LQX Health Technology Inc.

FDA registration
Guangdong Shunde LQX Health Technology Inc.·24 products·🇨🇳 China

IQK-200

FDA 510(k)
FDA Class 2 ·Anesthesiology

Carbon Dioxide L3K

FDA UDI
SEKISUI DIAGNOSTICS, LLC·00628063400003·

ETHANOL L3K Assasy

FDA UDI
SEKISUI DIAGNOSTICS, LLC·00628063400492·

TOTAL BILIRUBIN L3K

FDA UDI
SEKISUI DIAGNOSTICS, LLC·00628063400171·

Acetaminophen L3K Assay

FDA UDI
SEKISUI DIAGNOSTICS, LLC·00628063401215·

Tin Lok (Dongguan) Dental Laboratory Company Limited

FDA registration
Tin Lok (Dongguan) Dental Laboratory Company Limited·9 products·🇨🇳 China

LEAD-LOK, INC. d.b.a Nissha Medical Technologies

FDA registration
LEAD-LOK, INC. d.b.a Nissha Medical Technologies·8 products·🇺🇸 United States

enigmalife Denture Teeth - Pairs C1:L3K

FDA UDI
DAVIS SCHOTTLANDER & DAVIS LIMITED·05052674023651·