Intuitive Surgical
29 named things its latest annual report says its results depend on, each in the company's own words. 19 of them are also named by other companies we've read.
Suppliers
Sole-source and single-source suppliers
depends onnamed as a riskSome of the components necessary for the assembly of our products are currently provided to us by sole-sourced suppliers or single-sourced suppliers due to, among other things, quality considerations, unique intellectual property considerations, or constraints associated with regulatory requirements.Risk factors (Item 1A)
Partners and platforms
Fosun Pharma
depends onnamed as a riskIn 2019, the Joint Venture acquired certain assets related to the da Vinci distribution business of Chindex, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co. Ltd. (“Fosun Pharma”), following which the Joint Venture began direct distribution operations in China.Risk factors (Item 1A)
Baxter International Inc. (Hillrom)
depends onIntegrated Table Motion coordinates the movements of the da Vinci robotic arms with an advanced operating room (“OR”) table, the TS 7000dV OR Table sold by Hillrom (now a part of Baxter International Inc.).Business (Item 1)
Competitors
Johnson & Johnson
competes withnamed as a riskMoreover, as we add new robotically controlled products (e.g., da Vinci stapling and da Vinci energy products) that compete with product offerings traditionally within the domains of open surgery and/or conventional MIS, we face greater competition from larger and well-established companies, such as Johnson & Johnson and Medtronic plc.Business (Item 1)
Medtronic plc
competes withnamed as a riskMoreover, as we add new robotically controlled products (e.g., da Vinci stapling and da Vinci energy products) that compete with product offerings traditionally within the domains of open surgery and/or conventional MIS, we face greater competition from larger and well-established companies, such as Johnson & Johnson and Medtronic plc.Business (Item 1)
Remanufactured third-party instruments
competes withnamed as a riskAs of the filing date, we are aware that the FDA has granted 510(k) clearance for the remanufacturing of certain of these instruments for use with our da Vinci Si, da Vinci X, and da Vinci Xi surgical systems.Risk factors (Item 1A)
Places
Mexicali, Mexico
concentrated in · a significant majority of our instruments and accessoriesnamed as a risk•changes in tariffs, trade barriers, and regulatory requirements, such as the enactment of tariffs on goods imported into the U.S. including, but not limited to, potential tariffs on goods imported from Mexico where we manufacture a significant majority of our instruments and accessories that we sell;Risk factors (Item 1A)
Also named by SWKS
United States
earns from · 68%During the years ended December 31, 2025, 2024, and 2023, domestic revenue accounted for 68%, 67%, and 66%, respectively, of total revenue, while revenue from our OUS markets accounted for 32%, 33%, and 34%, respectively, of total revenue.Business (Item 1)
Also named by ABBV, ADP, AJG, AMGN, APA, AXGN, AXP, BALL and 139 more
China
operates innamed as a riskIn 2025, the effects of this campaign, combined with the competitive dynamics in China and various measures related to industrial policy, contributed to fewer systems being placed in China than we anticipated.Risk factors (Item 1A)
Also named by A, AA, AAOI, AAP, AAPL, AB, ADI, AEHR and 261 more
Switzerland
operates innamed as a riskFurther, Switzerland, which is the country from which we import our products into the EU and where our EU regulatory team is based, has not yet entered into a Mutual Recognition Agreement with the EU that covers the EU MDR and allows medical devices to move freely between Switzerland and the EU.Risk factors (Item 1A)
Sunnyvale, California
operates inWe manufacture our systems at our facilities in Sunnyvale, California, and Peachtree Corners, Georgia, as well as at our Joint Venture’s facility in Shanghai, China.Business (Item 1)
Hazards
California earthquakes and wildfires
operates innamed as a riskIf a major earthquake, wildfire, or other natural disaster were to damage our facilities or the facilities of our suppliers and service providers, or impact the ability of our employees or the employees of our suppliers and service providers to travel to their workplace, we may experience potential impacts ranging from production and shipping delays to lost revenues and increased costs, which could harm our business.Risk factors (Item 1A)
Commodities and inputs
U.S. dollar exchange rate
exposed to its price · approximately $140 millionnamed as a riskFor 2025, our revenue would have decreased by approximately $140 million if the U.S. dollar exchange rate strengthened by 10% against the foreign-denominated foreign currencies in which we sell.Market risk (Item 7A)
Rare earth elements
depends onnamed as a riskRare earth elements are critical to certain components contained in our products, and China is a predominant producer of these materials.Risk factors (Item 1A)
Conflict minerals (tantalum, tin, gold, tungsten)
exposed to its pricenamed as a riskIn addition, these metals are subject to price fluctuations and shortages that can affect our ability to obtain the manufactured materials that we rely on at favorable terms or from consistent sources.Risk factors (Item 1A)
Regulators
U.S. Food and Drug Administration (FDA)
subject tonamed as a riskIf the FDA were to identify non-conformances in our product documentation or quality system compliance, it could hold indefinitely the importation of instruments at the border, which would deprive us of the ability to sell and supply the majority of our customers until the FDA requirements have been satisfied.Risk factors (Item 1A)
Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more
Japan Ministry of Health, Labour and Welfare (MHLW)
subject tonamed as a riskIf these procedures are not adopted and we are not successful in obtaining adequate procedure reimbursements for additional procedures, then the demand for our products in Japan could be limited.Business (Item 1)
UK Medicines and Healthcare Products Regulatory Agency (MHRA)
subject tonamed as a riskThe divergence of the new UK rules from EU law could adversely affect or delay our ability to obtain approval for our medical device products in the UK.Risk factors (Item 1A)
Also named by COO
California Department of Health Services Food and Drug Branch
subject tonamed as a riskWe have been subject to periodic inspections by the California Department of Health Services Food and Drug Branch and, if we are unable to maintain this license following any future inspections, we will be unable to manufacture or ship some products, which would have a material adverse effect on our results of operations.Risk factors (Item 1A)
Laws and programs
EU Artificial Intelligence Act
subject to · up to 7% of worldwide annual turnovernamed as a riskOnce fully applicable, the EU AI Act and the revised EU Product Liability Directives will have a material impact on the way AI is regulated in the EU.Risk factors (Item 1A)
Also named by ABNB, ADP, AIOT, AKAM, ALAB, AMG, APP, AVAV and 24 more
China 2023 Quota for surgical robots
subject to · 559 new surgical robots; 162 da Vinci surgical systems placednamed as a riskAs of December 31, 2025, including systems that were sold in prior quarters, we have placed 162 da Vinci surgical systems under the original 2023 Quota and 5 da Vinci surgical systems under special approvals.Risk factors (Item 1A)
Medicare
subject tonamed as a riskIn general, the majority of payors, including Medicare, consider robotic assistance as a tool used to perform the procedure and do not pay providers more for a procedure that involves robotic assistance using the da Vinci, Ion, or any other robotic system.Business (Item 1)
Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more
One Big Beautiful Bill Act (OBBBA)
subject tonamed as a riskMore recently, the One Big Beautiful Bill Act (the “OBBBA”), enacted on July 4, 2025, contains provisions that, among other changes, may cause a decrease in enrollment in Medicaid and ACA marketplace plans, which could adversely affect demand for our products.Business (Item 1)
Also named by AA, ABR, ADI, ADM, ALB, AMAT, AMGN, AMKR and 121 more
China healthcare anti-corruption campaign
subject tonamed as a riskThis campaign resulted in heightened scrutiny by medical institutions with respect to initiating tenders, with some tenders being canceled or delayed without a timeline.Risk factors (Item 1A)
Also named by GEHC
China data laws (Cybersecurity Law, Data Security Law, PIPL)
subject tonamed as a riskWith the possibility of more stringent medical data transfer rules in China, customers’ appetite for our digital products including Onsite, Telepresence, and Case Insights may become impacted in the future.Risk factors (Item 1A)
Also named by TKO
China provincial robotic surgery price limits
subject tonamed as a riskTo date, these limits have impacted the number of procedures performed in those provinces as well as pricing of our instruments and accessories, which have impacted our instruments and accessories revenue.Risk factors (Item 1A)
U.S. tariffs on imports from Mexico, Germany, and China
subject tonamed as a riskIn addition, during 2025, the U.S. federal government imposed new tariffs on imports from various countries including Mexico, Germany, and China, among others.Risk factors (Item 1A)
EU Medical Devices Regulation (EU MDR)
subject tonamed as a riskIf we fail to comply with applicable laws and regulations, we would be unable to affix the CE mark to our products, which would prevent us from selling them within the EU.Risk factors (Item 1A)
Technology
GLP-1 weight loss drugs
competes withnamed as a riskThe availability and effectiveness of weight loss drugs have reduced the number of bariatric procedures performed, including those bariatric procedures performed using our da Vinci surgical system, as some patients reconsider the surgical treatment option.Risk factors (Item 1A)