510(k) Report

FDA applicant

Medicem Technology S.R.O

Kamenne Zehrovice2 decisions1986–20150 recalls

FDA records 2 decisions for Medicem Technology S.R.O (Kamenne Zehrovice) from 1986 to 2015: 1 510(k) clearance and 1 original PMA approval. Most are in product codes LOB (Dilator, Cervical, Synthetic, Osmotic…) and PKN (Dilator, Cervical, Synthetic, Osmotic). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Medicem Technology S.R.O’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medicem Technology S.R.O by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LOBDilator, Cervical, Synthetic, Osmotic, Pregnancy Termination1decision
  • PKNDilator, Cervical, Synthetic, Osmotic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K143447Dilapan-SMedicem Technology S.R.O · 20151cites it

What has FDA decided for it lately?

  • K143447Dilapan-SMedicem Technology S.R.O · 2015
  • P840045Dilapan-S Cervical DilatorMedicem Technology S.R.O · 1986

All 2 as Medicem Technology S.R.O →