Data / Medical devices / Netherlands / Edwards Lifesciences Holding B.V.
Edwards Lifesciences Holding B.V.: FDA-registered device maker in AMSTERDAM Noord-Holland, Netherlands, 3 510(k) clearances
Edwards Lifesciences Holding B.V. is registered with the FDA (registration 3042941992) in AMSTERDAM Noord-Holland, Netherlands. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 13, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042941992
- Address
- Centerpoint 1, 4TH Floor Hoogoorddreef 60, AMSTERDAM Noord-Holland, Netherlands, 1101 BE
- Owner or operator
- Becton, Dickinson and Company (10093301)
- Roles
- Specification developer
- First device listed
- May 6, 2025
- Registered through
- 2026
- Brand names listed
- Clearsight, Clearsight finger cuff, Clearsight system, EV1000 Clinical Platform NI, EV1000 Non-invasive, EV1000NI, Nexfin Model 2, Nexfin; Nexfin_HD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter | DQA | 2 | Specification developer | accessdata.fda.gov |
| Plethysmograph, Impedance | DSB | 2 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 13, 2014 | K140312 | EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM | DXN | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| April 22, 2013 | K122381 | NEXFIN MODEL 2 | DXN | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| November 29, 2007 | K072049 | CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS | DXN | Substantially Equivalent | Bmeye B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Plethysmograph, Impedance
Updated June 13, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.