9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
FLUID ADMINISTRATION LINE W/SPIKE 14-923
FDA 510(k)
FDA Class 2
·General Hospital
Cortex Screw, 3.5mm x 58mm, T15, Flex-Thread™
FDA UDI
FLOWER ORTHOPEDICS CORPORATION·00840118117340·Intramedullary fixation screw
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)
FDA 510(k)
FDA Class 1
·General Hospital
STRAIGHT ADJUSTER
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code LXH·June 2, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 21, 2012
J-VAC RESERVOIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GCY·September 17, 2010
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·March 13, 2026
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018