Unomedical Sdn Bhd: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Unomedical Sdn Bhd” (first 1995, latest 1998), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 53 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Convatec, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 7 | 7 |
| EZL | Catheter, Retention Type, Balloon | 2 | 2 |
Review panels
Most recent Unomedical Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973076 | EUROMEDICAL HAEMATURIA FOLEY CATHETER | EZL | 1998-09-16 | 394 |
| K962389 | EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE | BTR | 1996-11-21 | 154 |
| K954754 | WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE | BTR | 1995-12-08 | 53 |
| K954753 | PEDIATRIC SILICONE ENDOTRACHEAL TUBE | BTR | 1995-12-08 | 53 |
| K954751 | SILICONE ENDOTRACHEAL TUBE | BTR | 1995-12-08 | 53 |
| K954750 | PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE | BTR | 1995-12-08 | 53 |
| K951697 | PEDIATRIC ENDOTRACHEAL TUBE | BTR | 1995-05-22 | 40 |
| K951696 | ENDOTRACHEAL TUBE | BTR | 1995-05-22 | 40 |
| K945806 | SILICATH ALL SILICONE FOLEY CATHETER | EZL | 1995-03-21 | 113 |
Recalls
openFDA lists no recalls under a recalling firm named Unomedical Sdn Bhd.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Unomedical A/S (13 510(k)s)
- Unomedical A/S Infusion Devices (1 510(k)s)
- Unomedical Devices S.A DE C.V. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Unomedical Sdn Bhd?
FDA lists 9 510(k) clearances under the applicant name “Unomedical Sdn Bhd” (first 1995, latest 1998), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Unomedical Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unomedical Sdn Bhd is 53 days.
Which FDA product codes appear under Unomedical Sdn Bhd?
The most frequent FDA product codes under this applicant name are BTR (Tube, Tracheal (W/Wo Connector), 7); EZL (Catheter, Retention Type, Balloon, 2).
Next steps
- See all 9 Unomedical Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code BTR, Unomedical Sdn Bhd'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.