22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTI-SNARE SET
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012116·Zirlux 16+ D2 95X18
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324691·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324707·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324714·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324752·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324721·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324660·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324738·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324677·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324769·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324684·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324653·
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND
FDA 510(k)
FDA Class 2
·Orthopedic
2.0/2.4 CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·March 19, 2013
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
FDA Adverse Event
Other
·THERAKOS·Product code LNR·February 22, 2011
GE OEC 6600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 11, 2008
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018