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Dilapan-S

MEDICEM Technology s.r.o. · Model DS465 · UDI-DI 08595231704657

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.

Recalls

Date	Firm	Reason
2020-06-03	CooperSurgical, 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 display box indicat
2019-11-13	Medtronic Xomed, Inc.	Routine sterilization dose does not meet the required Sterility Assurance Level.
2019-11-13	Medtronic Xomed, Inc.	Routine sterilization dose does not meet the required Sterility Assurance Level.
2019-11-13	Medtronic Xomed, Inc.	Routine sterilization dose does not meet the required Sterility Assurance Level.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.