FDA Device Intelligence
HomeDevice types › KOH

Instrument, Manual, General Obstetric-Gynecologic

FDA product code KOH · Class 1 · Obstetrics/Gynecology

300
Registered devices
95
Adverse events
2
Recalls
15
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2021-04-15Boston Scientific CorporationPotential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infect
2003-02-20Portex, IncMay have incorrectly printed graduation markings along the tube shaft.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.