21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOVEL PRINT CYAN ALGINATES
FDA 510(k)
FDA Class 2
·Dental
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324981·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324899·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324950·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324905·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324882·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324912·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324943·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324936·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324974·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324967·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324929·
KSEA DION-GRACIA SET
FDA 510(k)
FDA Class 2
·Cardiovascular
SURGISIS PERIPHERAL VASCULAR PATCH
FDA 510(k)
FDA Class 2
·Cardiovascular
WS TITAMAX IMPLANT 4.0X5
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·May 9, 2018
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
FDA Adverse Event
Other
·THERAKOS·Product code LNR·February 22, 2011
GE OEC 9800
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