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Sign in to claim this brandONDAMED INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 5 FAIRLAWN DR STE 200, WASHINGTONVILLE, NY, 10992
- Website
- ondamed.net
- —
- —
- [email protected]
- Phone
- 8455340456
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3011088301
- DUNS Number
- 841720167
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ondamed | 001-05-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-50-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-55-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-52-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-03-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-01-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-53-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-00-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-54-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-56-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-04-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-21-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-02-0101 | FDA UDI | Class II | Active |
| RebaPad | 002-60-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-51-0101 | FDA UDI | Class II | Active |
| Ondamed | 001-57-0101 | FDA UDI | Class II | Active |
Related Companies
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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 |
|---|---|---|---|---|
| Jul 7, 2017 | Z-1782-2018 | — | terminated | The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has notified customers that an upgrade for the device is now available, which includes the addition of direct readout and audio signals for heart rate, and visual patient readout of blood oxygen content SpO2. |