22 results
·
29ms
·
Sources: EU EUDAMED, US FDA
DRG QUICKMIX
FDA 510(k)
FDA Class 2
·Neurology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040011706·Zirlux 16+ C4 95X14
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780842·LEVAMED ACTIVE ANKLE SUP SLVR R VI
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033337127·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033337097·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033337110·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033337080·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033337141·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033337103·
GALEO HYDRO AND GALEO HYDRO J-TIP
FDA 510(k)
FDA Class 2
·Cardiovascular
RD-3008
FDA 510(k)
FDA Class 2
·Dental
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 24, 2025
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code FZP·October 11, 2016
TRIATHLON CR X3 TIBIAL INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·March 19, 2013
MAHURKAR 13.5FR X 16CM SE KIT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MPB·February 14, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 11, 2008
CFF03, 5X100 KII FIOS ADVFIX 6/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·September 29, 2015
SYRINGE S2 5ML 22GA 1-1/2IN BD CHINA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 17, 2020
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