9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
FDA 510(k)
FDA Class 2
·Microbiology
TKD SCALERS
FDA 510(k)
FDA Class 2
·Dental
SIMPLICITY SILVER SET SOFT INFUSION
FDA 510(k)
FDA Class 2
·General Hospital
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 8, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 21, 2011
CIDEX PLUS 28 DAY SOLUTION
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON·Product code LRJ·May 9, 2008
VITEK® 2 AST-N350
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 17, 2018
VITEK® 2 AST-N350
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 17, 2018
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016