16 results
·
32ms
·
Sources: EU EUDAMED, US FDA
VISUAL BLOOD GLUCOSE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 11, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 11, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 11, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 11, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 11, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 11, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 11, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 11, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 11, 2024
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 19, 2014
HU-FRIEDY KIRKLAND KNIFE
FDA Adverse Event
Other
·HU-FRIEDY MFG. CO.,INC.·Product code EIX·October 21, 2010
MIXJECT TRANSFER DEVICE
FDA Adverse Event
Death
·MEDIMOP MEDICAL PROJECTS, LTD.·Product code LHI·December 19, 2012
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
FDA Enforcement
Class II
·Terminated·Cardinal Health·September 7, 2016