21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOZTECT SENSOR AND BIOZTECT CABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012246·Zirlux 16+ B2 95X20
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 14, 2013
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 14, 2013
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033331194·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033331248·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033331200·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033331224·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033331217·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033331163·
READERS CHOICE
FDA UDI
FGX INTERNATIONAL INC.·00193033331231·
RUSCH MILLER-ABBOTT TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUICKVUE DIPSTICK STREP A
FDA 510(k)
FDA Class 1
·Microbiology
TROCAR
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DYB·June 5, 2018
CANES
FDA Adverse Event
PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IPS·March 19, 2013
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·February 9, 2011
FIRE STAR RX PTCA BALLOON CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code LOX·March 11, 2008
ENDOPATH ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 23, 1997
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