Classification is based on semantic text similarity scoring and may include approximations. “No match” means no high-confidence textual match was found — not necessarily that a section was removed.

🟢 New in Current Filing Severity7/10Det 7

Our products are continually subject to clinical trials and other analyses conducted by us, our competitors or other third parties, the results of which may be unexpected, or perceived as unfavorable by the market, and could have a material adverse effect on our business, financial condition or results of operations.

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As a part of the regulatory process of obtaining marketing clearance for new products and new indications for existing products, we conduct and participate in numerous clinical trials with a variety of study designs, patient populations and trial endpoints. Unexpected or inconsistent clinical data from existing or future clinical trials or other analyses conducted by us, by our competitors or by third parties, including acquired businesses prior to acquisition by us, or the FDA's or the market's perception of this clinical data, may adversely impact our ability to obtain product approvals, our position in, and share of, the markets in which we participate and our business, financial condition, results of operations or future prospects. 22 22 22

🔴 No Match in Current Filing Any failure to meet regulatory quality standards applicable to our manufacturing and quality processes could have an adverse effect on our business, financial condition and results of operations. 🔒

🟡 Modified We may not realize the expected benefits from our restructuring and optimization initiatives, our long-term cost savings programs may result in an increase in short-term expenses and our efforts may lead to unintended consequences. 🔒

🟡 Modified Changes in tax laws, unfavorable resolution of tax contingencies, or exposure to additional income tax liabilities could have a material impact on our financial condition, results of operations and/or liquidity. 🔒

🟡 Modified Continued consolidation in the health care industry or additional governmental controls exerted over pricing in and access to key markets could lead to increased demands for price concessions or limit or eliminate our ability to sell certain of our products, which could have an adverse effect on our business, financial condition or results of operations. 🔒

🟡 Modified Health care cost containment pressures, government payment and delivery system reforms, changes in private payer policies, and marketplace consolidations could decrease the demand for our products, the prices which customers are willing to pay for those products and/or the number of procedures performed using our devices, which could have an adverse effect on our business, financial condition or results of operations. 🔒

🟡 Modified Our business and operations are subject to risks related to natural disasters, climate change and other extreme weather. 🔒

🟡 Modified Any failure to meet regulatory quality standards applicable to our manufacturing and quality processes could have an adverse effect on our business, financial condition and results of operations. 🔒

🟡 Modified We may experience declines in market size, average selling prices for our products, medical procedure volumes and/or our share of the markets in which we compete, which could have an adverse effect on our business, financial condition or results of operations. 🔒

8 more changes in this filing

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