Seamed Corp.: FDA clearances and approvals
Seamed Corp. has 18 FDA 510(k) clearances (first 1982, latest 1992), across 3 product codes in 1 review panel. Median 510(k) review time: 78 days.
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 |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | 13 | 13 |
| DTC | Analyzer, Pacemaker Generator Function | 4 | 4 |
| JOQ | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | 1 | 1 |
Review panels
- Cardiovascular (18)
Most recent Seamed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923398 | CPI MODEL 2215 | DTE | 1992-08-14 | 35 |
| K915364 | CHRONOCOR VI MODEL 5012 | DTE | 1992-02-07 | 72 |
| K912507 | CPI MODEL 2215 & SEAMED MODEL 3400 | DTE | 1991-09-03 | 89 |
| K910223 | CPI MODEL 2215/SEAMED MODEL 3400 | DTC | 1991-03-19 | 60 |
| K883930 | SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY | DTE | 1988-11-09 | 55 |
| K872551 | SEAMED MODEL 3200 | DTE | 1987-07-31 | 32 |
| K863903 | SEA MED MODEL 6000 | DTE | 1986-12-10 | 64 |
| K860462 | SEAMED MODEL 3000 | DTC | 1986-08-19 | 194 |
| K854648 | SEAMED MODEL 4000 | DTE | 1986-01-16 | 58 |
| K852746 | EXTERNAL PACEMAKER TELECTRONICS TE200 | JOQ | 1985-09-12 | 77 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Seamed Corp..
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 Seamed Corp. have?
Seamed Corp. has 18 FDA 510(k) clearances (first 1982, latest 1992), across 3 product codes in 1 review panel.
How long does FDA take to clear Seamed Corp.'s 510(k)s?
The median time from FDA receipt to decision across Seamed Corp.'s cleared 510(k)s is 78 days.
What devices does Seamed Corp. make?
Its most frequent FDA product codes are DTE (Pulse-Generator, Pacemaker, External, 13); DTC (Analyzer, Pacemaker Generator Function, 4); JOQ (Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only), 1).
Has Seamed Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Seamed Corp. Related entities may recall under other names.
Next steps
- See all 18 Seamed Corp. clearances with predicates and recalls
- Run predicate analysis for product code DTE, Seamed Corp.'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.