22 results
·
20ms
·
Sources: EU EUDAMED, US FDA
WORLAND UNICONDYLAR TIBIAL BEARING
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012222·Zirlux 16+ A4 95X20
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033325476·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033325513·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033325490·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033325520·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033325469·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033325506·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033325483·
CAPNOPROBE SL, MODEL 2000
FDA 510(k)
FDA Class 2
·Anesthesiology
THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD
FDA 510(k)
FDA Class 2
·General Hospital
RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 10, 2019
Fuhrman
FDA UDI
COOK INCORPORATED·00827002557260·Fuhrman Pleural and Pneumopericardial Drainage ...
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·March 19, 2013
SUPER POLIGRIP
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·February 21, 2011
FIRE STAR RX PTCA BALLOON CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code LOX·March 11, 2008
BONE SCREW Ø6,5 H.25MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LPH·November 24, 2021
C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·November 14, 2016
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