Medical device manufacturer
Edwards Lifesciences, LLC
Edwards Lifesciences, LLC holds 156 FDA 510(k) clearances across 40 product codes. Median elapsed review time is 107 days. openFDA lists 171 recall records naming the company. FDA publishes it under 11 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 156
- Product codes
- 40
- Median review
- 107 days
- Recall records
- 171
How does FDA spell Edwards Lifesciences, LLC?
FDA publishes this company under 11 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| EDWARDS LIFESCIENCES LLC | device/registrationlisting | normalised |
| Edwards Lifesciences | device/registrationlisting | normalised |
| Edwards Lifesciences | device/510k | normalised |
| Edwards Lifesciences AG | device/recall | normalised |
| Edwards Lifesciences LLC | device/registrationlisting | normalised |
| Edwards Lifesciences LTD | device/registrationlisting | normalised |
| Edwards Lifesciences Llc | device/recall | normalised |
| Edwards Lifesciences, LLC | device/recall | normalised |
Showing 8 of 11.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Edwards Lifesciences, LLC file in?
40 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 19 | 119 days | |
| DQK | Computer, Diagnostic, Programmable | 15 | 162 days | |
| DYB | Introducer, Catheter | 14 | 87 days | |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 11 | 104 days | |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 9 | 126 days | |
| KRH | Ring, Annuloplasty | 9 | 88 days | |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 7 | 27 days | |
| DXE | Catheter, Embolectomy | 6 | 173 days | |
| DXC | Clamp, Vascular | 5 | 40 days | |
| DXO | Transducer, Pressure, Catheter Tip | 5 | 112 days | |
| DYG | Catheter, Flow Directed | 5 | 115 days | |
| DQE | Catheter, Oximeter, Fiber-Optic | 4 | 63 days | |
| KRA | Catheter, Continuous Flush | 4 | 135 days | |
| MUD | Oximeter, Tissue Saturation | 4 | 171 days | |
| DQY | Catheter, Percutaneous | 3 | 41 days | |
| DRS | Transducer, Blood-Pressure, Extravascular | 3 | 102 days | |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 | 125 days | |
| MJN | Catheter, Intravascular Occluding, Temporary | 3 | 60 days | |
| QAQ | Adjunctive Predictive Cardiovascular Indicator | 3 | 265 days | |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 29 days | |
| LDF | Electrode, Pacemaker, Temporary | 2 | 17 days | |
| OZT | Balloon Aortic Valvuloplasty | 2 | 79 days | |
| BZQ | Monitor, Breathing Frequency | 1 | 408 days | |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 147 days | |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 | 78 days |
Showing the 25 they file in most, of 40.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Edwards Lifesciences, LLC had a recall?
openFDA lists 171 recall records naming this company across its whole history, of which 1 was opened in the last 12 months and is not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2172-2026Class IIOpen, ClassifiedNPW
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Z-2080-2025Class IOpen, ClassifiedDQR
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2081-2025Class IOpen, ClassifiedDQR
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2082-2025Class IOpen, ClassifiedDQR
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2083-2025Class IOpen, ClassifiedDQR
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Showing the 5 most recently initiated of 171.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Edwards Lifesciences, LLC cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) | PZX | 179 | |
| K251326 | Respiration Rate algorithm | BZQ | 408 | |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | DXC | 143 | |
| K254279 | Edwards eSheath+ introducer set | DYB | 108 | |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | DQK | 151 | |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | DQK | 128 | |
| K253034 | HemoSphere Stream Module | DQK | 29 | |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | KRH | 88 | |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | KRH | 107 | |
| K252364 | Edwards eSheath Optima introducer set | DYB | 31 |
Source: openFDA device/510k · retrieved
Where is Edwards Lifesciences, LLC registered?
FDA lists 4 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Edwards Lifesciences, LLC files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.