Dot Medical Products , Ltd.: FDA clearances and approvals
Dot Medical Products , Ltd. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MTE | System, Pacing, Temporary, Acute, Internal Atrial Defibrillation | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990069 | PMA | ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08) | 2002-11-27 |
Recalls
openFDA lists no recalls under a recalling firm named Dot Medical Products , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dot Medical Products , Ltd. have?
Dot Medical Products , Ltd. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Dot Medical Products , Ltd. make?
Its most frequent FDA product codes are MTE (System, Pacing, Temporary, Acute, Internal Atrial Defibrillation, 1).
Has Dot Medical Products , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dot Medical Products , Ltd. Related entities may recall under other names.
Next steps
- See all 0 Dot Medical Products , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MTE, Dot Medical Products , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.