Edwards Laboratories: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Edwards Laboratories” (first 1976, latest 1980), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 20 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 |
|---|---|---|---|
| DTK | Filter, Intravascular, Cardiovascular | 3 | 3 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 3 | 3 |
| DTJ | Holder, Heart-Valve, Prosthesis | 2 | 2 |
| KRB | Probe, Thermodilution | 2 | 2 |
| DQC | Phonocardiograph | 1 | 1 |
| KRH | Ring, Annuloplasty | 1 | 1 |
Review panels
- Cardiovascular (12)
Most recent Edwards Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K801552 | MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR | KRB | 1980-07-28 | 20 |
| K800655 | MODEL 100 SPECTRAVIEW | DQC | 1980-04-16 | 22 |
| K792441 | CARPENTIER-EDWARDS FLEX. ANNULOPLASTY | KRH | 1980-03-17 | 109 |
| K792034 | INTEGRAL DISPOSABLE HOLDER CARPENTIER | DTJ | 1979-12-07 | 58 |
| K790047 | CARDIAC OUTPUT COMPUTER, MDEL 9520A | DXG | 1979-02-26 | 52 |
| K790022 | DISPOSABLE HOLDER FOR BIOPROSTHESIS | DTJ | 1979-01-15 | 12 |
| K781535 | AC ADAPTER:MODELS 9525,9526,9527 | DXG | 1978-09-15 | 9 |
| K771663 | PROBE & CATHETER | KRB | 1977-09-20 | 21 |
| K771046 | VENA CAVA UMBRELLA FILTER, MODEL 7321 | DTK | 1977-06-22 | 12 |
| K760151 | APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) | DTK | 1976-08-26 | 56 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Edwards Laboratories.
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 Lifesciences Research Medical (6 510(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 Laboratories?
FDA lists 12 510(k) clearances under the applicant name “Edwards Laboratories” (first 1976, latest 1980), across 6 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 Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Edwards Laboratories is 20 days.
Which FDA product codes appear under Edwards Laboratories?
The most frequent FDA product codes under this applicant name are DTK (Filter, Intravascular, Cardiovascular, 3); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 3); DTJ (Holder, Heart-Valve, Prosthesis, 2).
Next steps
- See all 12 Edwards Laboratories clearances with predicates and recalls
- Run predicate analysis for product code DTK, Edwards Laboratories'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.