Ep Medsystems

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K092913EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04October 16, 2009
K073709MODIFICATION TO VIEWMATE SYSTEMMarch 11, 2008
K071028VIEWMATE SYSTEMMay 1, 2007
K070706EP-WORKMATEApril 11, 2007
K063277MAPMATENovember 30, 2006
K063113EP-WORKMATEOctober 27, 2006
K041442EP-4 CLINICAL STIMUTATORSeptember 14, 2004
K033963EP DEFLECTABLE CATHETERSApril 15, 2004
K040207EP-4 CLINICAL STIMULATORFebruary 27, 2004
K031066VIEWMATE ULTRASOUND IMAGING SYSTEMOctober 17, 2003
K032225EP-WORKMATE WITH RPM SYSTEMAugust 20, 2003
K994011EP MEDSYSTEMS, EP-WORKMATEMarch 23, 2000
K991001MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETERJuly 15, 1999
K984150PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETERFebruary 22, 1999
K961513PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SETMay 13, 1996