Radi Medical Systems AB

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K123984QUANTIEN MEASUREMENT SYSTEMMarch 28, 2013
K092105RADIANALYZER XPRESSOctober 9, 2009
K080813PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVERJuly 1, 2008
K080206MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEMFebruary 26, 2008
K062769PRESSUREWIRE CERTUS, MODELS 12006 AND 12306December 4, 2006
K042628MODIFICATION TO: RADIANALYZER, MODEL 12711January 19, 2005
K033291TOPSEAL HEMOSTATIC DRESSING, MODEL 11150March 17, 2004
K031662PRESSURE WIRE SENSOR, MODELS 12004/12304June 6, 2003
K024107FEMOSTOP FEMORAL COMPRESSION SYSTEMDecember 24, 2002
K022188RADIANALYZER, MODEL 12710October 3, 2002
K022187PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304September 24, 2002
K013943RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720December 18, 2001
K002067RADIANALYZER, MODEL 12710January 11, 2001
K002962PRESSURE WIRE SENSOR, MODEL 12003/12303October 4, 2000
K983471FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTERFebruary 23, 1999
K983506PRESSUREWIRE SENSOR, MODEL #12001February 3, 1999
K982182FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOPSeptember 18, 1998
K972793PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLEApril 24, 1998
K980898FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADApril 21, 1998
K962425BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)September 11, 1996