Is this your brand? Sign in to claim ownership.
Sign in to claim this brandInfinium Medical, Inc.
US
Last updated September 17, 2026
About
Infinium Medical manufacturers patient monitoring systems and critical care equipment ideal for emergency response and surgery procedures.
From the manufacturer's own website. Source
Information
- Country
- US
- Address
- 12151 62ND ST., N,, Largo, FL, 33773
- Website
- infiniummedical.com
- linkedin.com/company/infiniummedical
- facebook.com/infiniummedical
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3007513035
- DUNS Number
- —
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Infinium Medical | OMNI Express | FDA UDI | Class II | Active |
| Schiller Americas | T Lite | FDA UDI | Class II | Active |
| Edge | 160 | FDA UDI | Class II | Active |
| Infinium Medical | OMNI III | FDA UDI | Class II | Active |
| Edge | R80 | FDA UDI | Class II | Active |
| Infinium Medical | CLEO | FDA UDI | Class II | Active |
| Edge | 400 | FDA UDI | Class II | Active |
| Axia | V1050T | FDA UDI | Class II | Active |
| Infinium Medical Inc. | OBA MRI Compatible Anesthesia Machine | FDA UDI | Class II | Active |
| Infinium Medical | OMNI K | FDA UDI | Class II | Active |
| Axia | TRIA | FDA UDI | Class II | Active |
| Edge | 200 | FDA UDI | Class II | Active |
| Infinium Medical | OMNI | FDA UDI | Class II | Active |
| Infinium Medical | OMNI II K | FDA UDI | Class II | Active |
| Infinium Medical | OMNI II | FDA UDI | Class II | Active |
| Axia | V1500A | FDA UDI | Class II | Active |
| Axia | V1200T | FDA UDI | Class II | Active |
| Schiller Americas | Tranquility II | FDA UDI | Class II | Active |
| Schiller Americas | Tranquility VS | FDA UDI | Class II | Active |
| Infinium Medical Inc. | OBA Anesthesia Machine | FDA UDI | Class II | Active |
| Omni Iii Patient Monitor | K101052 | FDA 510(k) | Class II | Active |
| Omni Patent Monitors | K132229 | FDA 510(k) | Class II | Active |
| Omni Express | K103268 | FDA 510(k) | Class II | Active |
| Cleo Patient Monitor | K142244 | FDA 510(k) | Class II | Active |
| Omni Ii Patient Monitor | K103737 | FDA 510(k) | Class II | Active |
| Omni Patient Monitor | K112329 | 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 (1)
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 |
|---|---|---|---|---|
| May 31, 2019 | Z-1926-2019 | — | open, classified | The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option. |