Edwards Lifesciences
Heart valves, critical care monitoring and structural heart products.
Edwards Lifesciences manufactures heart valves, critical care monitoring and structural heart products from its Irvine operations. The company supplies healthcare systems, laboratories, OEM partners or regulated export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Irvine, United States
- Founded
- 1958
- Website
- edwards.com
- Categories
- Medical & Healthcare Supplies
- Markets
- United States, Germany, Japan, China
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- facility-registered (green), checked 2026-08-07 US EPA Facility Registry Service (national combined file)
- fda-registered (green), checked 2026-08-08 FDA
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- lei-active (green), checked 2026-08-08 GLEIF
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)