Edwards Lifesciences Research Medical: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Edwards Lifesciences Research Medical” (first 1998, latest 2008), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 156 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 Edwards Lifesciences, 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 4 | 4 |
| DQR | Cannula, Catheter | 1 | 1 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Edwards Lifesciences Research Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073559 | 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II | DQR | 2008-01-31 | 43 |
| K062429 | MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH | DTM | 2006-09-27 | 37 |
| K990396 | T-ANASTAFLO | DWF | 1999-10-01 | 234 |
| K991170 | RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 | DWF | 1999-07-02 | 86 |
| K983791 | PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA | DWF | 1999-06-11 | 227 |
| K974259 | VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE | DWF | 1998-12-01 | 383 |
Recalls
17 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2009-09-24.
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.
- Edwards Lifesciences, LLC (156 510(k)s)
- Edwards Pacemaker Systems (13 510(k)s)
- Edwards Laboratories (12 510(k)s)
- Edwards Lifeciences, LLC (3 510(k)s)
- Edwards Lifesciences Services GmbH (3 510(k)s)
- Edwards Lifesiences, LLC (2 510(k)s)
- Edwards Orthopaedics Div., Baxter Healthcare Corp. (2 510(k)s)
- Edwards Lfesciences (1 510(k)s)
- Edwards Lifescience, LLC (1 510(k)s)
- Edwards Lifesciencess, LLC (1 510(k)s)
- Edwards Ventilator Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Edwards Lifesciences Research Medical?
FDA lists 6 510(k) clearances under the applicant name “Edwards Lifesciences Research Medical” (first 1998, latest 2008), across 3 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 Edwards Lifesciences Research Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Edwards Lifesciences Research Medical is 156 days.
Which FDA product codes appear under Edwards Lifesciences Research Medical?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 4); DQR (Cannula, Catheter, 1); DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 1).
Next steps
- See all 6 Edwards Lifesciences Research Medical clearances with predicates and recalls
- Run predicate analysis for product code DWF, Edwards Lifesciences Research Medical'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.