Company ยท US
Osypka Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2013. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2013 | K123916 | PSA SERIES Osypka Medical, Inc. | DTE |
| Oct 8, 2008 | K082242 | ICON, MODEL C3 Osypka Medical, Inc. | DSB |
| May 30, 2008 | K081035 | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 Osypka Medical, Inc. | DSB |
| Feb 1, 2008 | K070985 | AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC Osypka Medical, Inc. | DSB |
| Oct 31, 2003 | K033130 | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR Osypka Medical, Inc. | DTE |
| Oct 3, 2002 | K022939 | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES Osypka Medical, Inc. | DTE |
| Jun 14, 2002 | K020896 | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE Osypka Medical, Inc. | DTE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2010 | Osypka Medical Inc St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator
The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead sy Terminated |
DTE | K020896 |
| Sep 21, 2010 | Osypka Medical Inc Oscor PACE 203H, Dual-Chamber External Pulse Generator
The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for tem Terminated |
DTE | K020896 |