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Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA product code LOB · Class 3 · Unknown

3
Registered devices
2
Adverse events
4
Recalls
0
510(k) clearances

Devices with this code

Dilapan-S — MEDICEM Technology s.r.o.Dilapan-S — MEDICEM Technology s.r.o.Dilapan-S — MEDICEM Technology s.r.o.

Recent recalls

DateFirmReason
2020-06-03CooperSurgical, Inc.Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the
2019-11-13Medtronic Xomed, Inc.Routine sterilization dose does not meet the required Sterility Assurance Level.
2019-11-13Medtronic Xomed, Inc.Routine sterilization dose does not meet the required Sterility Assurance Level.
2019-11-13Medtronic Xomed, Inc.Routine sterilization dose does not meet the required Sterility Assurance Level.

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