Inrad

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243886ExpressCore Biopsy DeviceApril 29, 2025
K240429Trilogy Tissue MarkerNovember 7, 2024
K183503EasyMark Tissue MarkerOctober 17, 2019
K112945ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITERNovember 3, 2011
K093399PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520November 19, 2009
K093256SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018November 17, 2009
K090611REVOLUTION FULL CORE BIOPSYJune 4, 2009
K063238ULTRACLIP II WING AND ULTRACLIP II COILJanuary 30, 2007
K042341ULTRACLIP II USSeptember 20, 2004
K041201ULTRACLIP II MRJune 3, 2004
K000612ACCUCORE SINGLE ACTION CORE BIOPSY DEVICEApril 24, 2000
K993785ULTRACLIP TISSUE MARKERFebruary 4, 2000
K981721C0-AXIAL INTRODUCER NEEDLEJuly 28, 1998
K981166ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 58June 22, 1998
K980587IV DECANTER-FLEXIBLEApril 17, 1998