Medicem Technology S.R.O: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Medicem Technology S.R.O” (first 2015, latest 2015), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 136 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 136 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOB | Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination | 1 | 0 |
| PKN | Dilator, Cervical, Synthetic, Osmotic | 1 | 1 |
Review panels
Most recent Medicem Technology S.R.O 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143447 | Dilapan-S | PKN | 2015-04-17 | 136 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P840045 | PMA | DILAPAN-S CERVICAL DILATOR | 1986-04-28 |
Recalls
openFDA lists no recalls under a recalling firm named Medicem Technology S.R.O.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medicem Technology S.R.O?
FDA lists 1 510(k) clearance under the applicant name “Medicem Technology S.R.O” (first 2015, latest 2015), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medicem Technology S.R.O?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicem Technology S.R.O is 136 days.
Which FDA product codes appear under Medicem Technology S.R.O?
The most frequent FDA product codes under this applicant name are LOB (Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination, 1); PKN (Dilator, Cervical, Synthetic, Osmotic, 1).
Next steps
- See all 1 Medicem Technology S.R.O clearances with predicates and recalls
- Run predicate analysis for product code LOB, Medicem Technology S.R.O's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.