Is this your brand? Sign in to claim ownership.
Sign in to claim this brandOsypka Medical, Inc.
US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cardiotronic | ICON | FDA UDI | Class II | Active |
| Osypka Medical | PSA 200 | FDA UDI | Class II | Active |
| Cardiotronic | PACE 101 | FDA UDI | Class II | Active |
| Cardiotronic | PACE 101 | FDA UDI | Class II | Active |
| Cardiotronic | PACE 203 | FDA UDI | Class II | Active |
| Cardiotronic | PACE 203 | FDA UDI | Class II | Active |
| Aesculon C2, Aesculon Chf Clinic C2, Aesculon Hypertension Clinic C2 And Aesculon Pacemaker Clinic C2 | K081035 | FDA 510(k) | Class II | Active |
| Oscor Pace 203/Pace 203h Dual-Chamber Temporary Pacemaker, St. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene | K020896 | FDA 510(k) | Class II | Active |
| Psa Series | K123916 | FDA 510(k) | Class II | Active |
| Pace 101/Pace 101h, Model 3077 Ssi Temporary Pulse Generator | K033130 | FDA 510(k) | Class II | Active |
| Aesculon Chf, Hypertension & Pacemaker Clinic | K070985 | FDA 510(k) | Class II | Active |
| Icon, Model C3 | K082242 | FDA 510(k) | Class II | Active |
| Oscor Pace 101/101h And Accessories, St.jude Medical Model 3077 And Accessories, Cardiotronic Pace 101 And Accessories | K022939 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 30, 2010 | Z-2443-2010 | — | terminated | The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with some new types of 9 V batteries. The investigation revealed that PACE 203H of a certain manufacturing period malfunction (i.e., not stimulate) when a type of 9 V batteries with higher than usual open circuit voltage (OCV) is used. Failure t |
| Jun 30, 2010 | Z-2444-2010 | — | terminated | The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with some new types of 9 V batteries. The investigation revealed that PACE 203H of a certain manufacturing period malfunction (i.e., not stimulate) when a type of 9 V batteries with higher than usual open circuit voltage (OCV) is used. Failure t |