Home › Device types › OSP
Uterine Electromyographic Monitor
FDA product code OSP · Class 2 · Obstetrics/Gynecology
13
Registered devices
9
Adverse events
3
Recalls
10
510(k) clearances
Devices with this code
NOVII INTERFACE CABLE — Datex-Ohmeda, Inc.Novii — MONICA HEALTHCARE LIMITEDNovii — MONICA HEALTHCARE LIMITEDNovii — MONICA HEALTHCARE LIMITEDNovii — Datex-Ohmeda, Inc.NOVII INTERFACE CABLE — Datex-Ohmeda, Inc.Monica — MONICA HEALTHCARE LIMITEDNovii — Datex-Ohmeda, Inc.TrueLabor Maternal Unit — O.B - TOOLS LTDEmbraceTM Electrodes Array (L) — O.B - TOOLS LTDNovii — MONICA HEALTHCARE LIMITEDTrueLabor Monitor Adapter — O.B - TOOLS LTDNOVII INTERFACE CABLE — Datex-Ohmeda, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-15 | GE Healthcare, LLC | if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signa |
| 2017-12-15 | GE Healthcare, LLC | if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signal |
| 2017-04-28 | MONICA HEALTHCARE LTD | Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging. |
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