20 results
·
19ms
·
Sources: EU EUDAMED, US FDA
K-ASSAY C1-INA
FDA 510(k)
FDA Class 2
·Immunology
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324332·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324349·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324363·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324370·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324394·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324400·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324387·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324417·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324325·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324318·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033324356·
COPAN VIRAL TRANSYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
TROCHANTERIC NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK ® SPIRIT ADAPTER
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·March 19, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·February 9, 2011
*
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JTC·February 12, 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
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012