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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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·