Osypka Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
2
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K123916PSA SERIESApril 9, 2013
K082242ICON, MODEL C3October 8, 2008
K081035AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC CMay 30, 2008
K070985AESCULON CHF, HYPERTENSION & PACEMAKER CLINICFebruary 1, 2008
K033130PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOROctober 31, 2003
K022939OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 10October 3, 2002
K020896OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBERJune 14, 2002