Home › Device types › HGP
Electrode, Circular (Spiral), Scalp And Applicator
FDA product code HGP · Class 2 · Obstetrics/Gynecology
32
Registered devices
279
Adverse events
3
Recalls
17
510(k) clearances
Devices with this code
Rocket — ROCKET MEDICAL PLCADVANCED FETAL MONITOR — ADVANCED INSTRUMENTATIONS, INC.Vital Signs — Carefusion Finland 320 OyKendall — Cardinal Health 200, LLCNA — Philips Medical Systems HsgVital Signs™ — AirLife Finland OyFetal Measurements — Philips Medical Systems HsgFSE Cables — CLINICAL INNOVATIONS, LLCKendall — Cardinal Health, Inc.N/A — Carefusion Finland 320 OyVital Signs™ — AirLife Finland OyFSE Cables — CLINICAL INNOVATIONS, LLCFSE Cables — CLINICAL INNOVATIONS, LLCFSE Cables — CLINICAL INNOVATIONS, LLCFetal Measurements — Philips Medical Systems HsgKendall — Cardinal Health, Inc.FSE Cables — CLINICAL INNOVATIONS, LLCGoldtrace Fetal Spiral Electrode (FSE) — Neoventa Medical ABKendall — Cardinal Health, Inc.FSE Cables — CLINICAL INNOVATIONS, LLCKendall — Cardinal Health, Inc.FSE Cables — CLINICAL INNOVATIONS, LLCNA — Philips Medical Systems HsgKendall — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-21 | Philips North America Llc | Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient |
| 2019-01-25 | Philips North America, LLC | During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery. |
| 2012-10-16 | Vital Signs Devices, a GE Healthcare Company | Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing. |
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