Risk Sleuth
EW · 10-K filed 25 Feb 2026 · year to 31 Dec 2025

Edwards Lifesciences

30 named things its latest annual report says its results depend on, each in the company's own words. 25 of them are also named by other companies we've read.

Read the filing on SEC.gov ↗

Customers

Group purchasing organizations (GPOs)

earns fromnamed as a risk
If we are not one of the providers selected by one of these organizations, we may be precluded from making sales to its members or participants.Risk factors (Item 1A)

Also named by BAX, BDX, BSX, CDW, GMED, GWW, SYY, USFD and 1 more

U.S. Veterans Administration

earns fromnamed as a risk
The health care industry has been consolidating, and organizations such as GPOs, independent delivery networks, and large single accounts, such as the United States Veterans Administration, continue to consolidate purchasing decisions for many of our health care provider customers.Risk factors (Item 1A)

Other companies

Becton, Dickinson and Company

named as a risk
On September 3, 2024, we sold our Critical Care product group to Becton, Dickinson and Company.Risk factors (Item 1A)

Also named by CDNA, WAT

Competitors

Medtronic plc

competes withnamed as a risk
In TAVR, our primary competitors include Medtronic plc (“Medtronic”) and Abbott Laboratories (“Abbott”).Business (Item 1)

Also named by ISRG, SYK

Abbott Laboratories

competes withnamed as a risk
In TMTT, our primary competitor is Abbott, and there are a considerable number of large and small companies with development efforts in these fields.Business (Item 1)

Also named by DXCM

Places

United States

earns from · 58% of our net sales
In 2025, 58% of our net sales were derived from sales to customers in the United States.Business (Item 1)

Also named by ABBV, ADP, AJG, AMGN, APA, AXGN, AXP, BALL and 139 more

Europe

earns from · 60%
Of the total sales outside of the United States, 60% were in Europe, 14% were in Japan, and 26% were in Rest of World.Business (Item 1)

Also named by ADSK, AME, AMRC, ATR, BCSF, BKNG, BMI, BMY and 60 more

Japan

earns from · 14%
Of the total sales outside of the United States, 60% were in Europe, 14% were in Japan, and 26% were in Rest of World.Business (Item 1)

Also named by A, AAPL, AFL, AMKR, ANET, BMY, BSX, CAT and 25 more

Switzerland

operates innamed as a risk
In addition, in the EU, we import some of our devices through our offices in Switzerland.Risk factors (Item 1A)

Also named by EL, GGG, HSY, ISRG, MTD

Israel

operates in
Our research and development activities are conducted primarily in facilities located in the United States and Israel.Business (Item 1)

Also named by AIOT, AKAM, AMAT, AMGN, APP, ASTS, AVY, BSX and 31 more

Australia

depends on
We obtain bovine tissue used in our pericardial tissue valve products only from sources within the United States and Australia, where strong control measures and surveillance programs exist.Business (Item 1)

Also named by AJG, ARWR, AXP, BF/B, BTU, CL, CSGP, CVX and 15 more

Ireland

operates in
We manufacture our TAVR, TMTT, and Surgical products primarily in the United States, Singapore, Costa Rica, and Ireland, to ensure continuity of care for patients in these regions and also worldwide.Business (Item 1)

Also named by AAPL, ACN, ADI, AGX, BEN, CDNS, CELH, COR and 13 more

Singapore

operates in
We manufacture our TAVR, TMTT, and Surgical products primarily in the United States, Singapore, Costa Rica, and Ireland, to ensure continuity of care for patients in these regions and also worldwide.Business (Item 1)

Also named by A, AAPL, ALAB, AMAT, ANET, APP, AVGO, DLR and 12 more

Costa Rica

operates in
We manufacture our TAVR, TMTT, and Surgical products primarily in the United States, Singapore, Costa Rica, and Ireland, to ensure continuity of care for patients in these regions and also worldwide.Business (Item 1)

Also named by COO, GMED

Hazards

Earthquakes

operates innamed as a risk
Disruptions can also occur if our manufacturing and warehousing facilities are damaged by earthquakes, hurricanes, volcanoes, fires, and other natural disasters or catastrophic circumstances.Risk factors (Item 1A)

Also named by AAPL, AMKR, AN, ANET, APP, BRO, CDNS, CEG and 37 more

Bovine spongiform encephalopathy (BSE)

named as a risk
Concerns relating to the potential transmission of animal-borne illnesses, including BSE, commonly known as “mad cow disease,” from cows to humans may result in reduced acceptance of products containing bovine materials.Risk factors (Item 1A)

Also named by JBTM

Commodities and inputs

Euro

exposed to its pricenamed as a risk
Our principal currency exposures relate to the Euro and the Japanese yen.Market risk (Item 7A)

Also named by ABBV, ABNB, ABT, ADBE, ADI, AME, AMG, AMGN and 186 more

Japanese yen

exposed to its pricenamed as a risk
Our principal currency exposures relate to the Euro and the Japanese yen.Market risk (Item 7A)

Also named by ABBV, ABT, ACN, ADBE, ALK, AMAT, AMKR, BMY and 24 more

Bovine tissue

depends onnamed as a risk
We obtain bovine tissue only from closely controlled sources within the United States and Australia.Risk factors (Item 1A)

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk
A prolonged government shutdown could significantly affect the FDA’s timely review of any regulatory filings or applications we submit, which could result in delays or failures to obtain or maintain regulatory approvals, clearances or to comply with regulatory requirements.Risk factors (Item 1A)

Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more

Centers for Medicare & Medicaid Services (CMS)

subject tonamed as a risk
Changes in current coverage and reimbursement levels could have an adverse effect on market demand and our pricing flexibility.Business (Item 1)

Also named by A, ABT, AMGN, AXGN, BAX, BWIN, CNC, COO and 23 more

Japanese Ministry of Health, Labour and Welfare

subject tonamed as a risk
Approval time frames from the Japanese Ministry of Health, Labour and Welfare vary from simple notifications to review periods of one or more years, depending on the complexity and risk level of the device.Business (Item 1)

Medicines and Healthcare products Regulatory Agency (MHRA)

subject to
Currently, the UK’s medical device legislation states that the access for CE-marked medical devices will end on June 30, 2030; however, the UK’s regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), has announced it will consult on extending the recognition of CE-marked products indefinitely.Business (Item 1)

Also named by GMED, HIMS, LH

Laws and programs

Medicare

earns fromnamed as a risk
HHS' Centers for Medicare & Medicaid Services (“CMS”) may also review whether and/or under what circumstances a procedure or technology is reimbursable for Medicare beneficiaries.Business (Item 1)

Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more

OECD Pillar Two

subject tonamed as a risk
The effective dates of implementation, the interactions of tax reforms in multiple jurisdictions, uncertainty related to dispute resolution mechanisms, and any ultimate agreement regarding treatment of the U.S. tax regime as a qualified side-by-side Pillar Two system, could impact our provision for income taxes.Risk factors (Item 1A)

Also named by APO, BAM, BAX, BF/B, CHRW, COHR, CPNG, CRM and 45 more

Affordable Care Act

subject tonamed as a risk
For example, in the United States, continued implementation of the Affordable Care Act and the 21st Century Cures Act, or any future legislation, including deficit reduction legislation, could impact medical procedure volumes, reimbursement for our products, and demand for our products or the prices at which we sell our products.Risk factors (Item 1A)

Also named by ABBV, ABT, ADP, AFL, BBSI, BRO, BWIN, COR and 8 more

EU Medical Device Regulation (MDR)

subject tonamed as a risk
During the transition period, with the influx of submissions to the notified bodies, any delay on obtaining approvals may result in a disruption of device supply or a further delay in getting a device to market.Risk factors (Item 1A)

Also named by ABBV, BAX, BDX, BSX, CAH, COO, DXCM, GEHC and 4 more

U.S. Section 232 investigation on medical devices

subject tonamed as a risk
Additionally, the U.S. Department of Commerce recently initiated an investigation under Section 232 of the Trade Expansion Act of 1962, as amended, into (among other things) imports of personal protective equipment, medical consumables and medical equipment (including devices), to determine whether they threaten U.S. national security, which further creates policy uncertainty in terms of tariffs.Risk factors (Item 1A)

Also named by BDX

EU-Switzerland Mutual Recognition Agreement

subject tonamed as a risk
In addition, a Mutual Recognition Agreement still under negotiation for the Medical Device Regulation may result in a lack of free movement of medical devices between the EU and Switzerland, may impact our access in the EU and may, ultimately, have a material effect on our business, financial condition, and results of operations.Risk factors (Item 1A)

U.S. national coverage determination for TAVR

subject tonamed as a risk
Even if we timely innovate and develop products, our ability to successfully market them could be limited by a number of different factors, including competitive products and pricing, barriers in patient activation (including disease awareness, detection, and diagnosis), restrictive requirements in the U.S. national coverage determination for transcatheter aortic valve replacement procedures, the need for regulatory clearance, restrictions imposed on approved indications, capacity constraints within hospital systems, including staffing shortages and the availability of catheterization laboratories, and uncertainty over third-party reimbursement.Risk factors (Item 1A)