Cardiomedics, Inc.

FDA Regulatory Profile

Cardiomedics, Inc. appears in FDA public data with 0 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on March 31, 2005.

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K050172CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000March 31, 2005
K023427CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000January 7, 2003
K022107CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000August 8, 2002
K010261CARDIOMEDICS ECP SYSTEMFebruary 28, 2001
K872034CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEMSeptember 18, 1987