The largest medtech companies, read through FDA records
Market value from public market data, next to what the FDA recorded about each company in the last 12 months: recalls by class, device warning letters, and CEO or CFO changes. Every figure links to its source.
Not investment advice. This page is general, impersonal information for educational purposes. It is not a recommendation to buy, sell or hold any security, is not tailored to anyone’s situation, and Norte Regulatorio is not a registered investment adviser or broker-dealer. The indicator is a rules-based summary of public FDA records and leadership announcements, not a rating, recommendation or forecast, and it says nothing about valuation, financial performance or future share prices. Market data can be delayed or wrong; verify at the source and consult a licensed financial professional before making any investment decision. Norte Regulatorio receives no compensation from any company listed.
Market capitalization (USD billions)
Source: companiesmarketcap.com, fetched 2026-10-10; values move during the trading day. Cross-checked with stockanalysis.com (within about 4%). * Diversified company: devices are only part of its business.
FDA activity indicator
How the indicator works (rules, not opinions): Red a CDRH device warning letter dated in the window, or 10 or more Class I recall records. Amber 1 to 9 Class I recall records, or a CEO change announced or effective in the window. Green none of the above. Window: 2025-10-10 to 2026-10-09. Larger companies sell more products and tend to have more records; the indicator is not adjusted for size. It does not measure product quality, legal compliance or financial performance; a recall record is not a recall event, and a recall or warning letter does not by itself indicate wrongdoing. Spot an error? hola@norteregulatorio.com and we will review and correct it promptly.
| Company | Ticker | Market cap | 12-month change | Class I / II / III recall records | Device warning letters | CEO / CFO changes | Indicator |
|---|
Leadership changes in the window
Warning letters found
Method and limits
- Recall counts are openFDA device/enforcement product records by report date, matched on the company name; one recall event can produce several records. The exact query for each company is linked from its count.
- openFDA data was last updated 2026-09-30, so the last days of the window are not yet included.
- Warning letters: only letters we could open on fda.gov are listed. FDA’s list cannot be searched completely from here, so “none found” does not mean none were issued.
- Leadership changes: confirmed in company press releases or SEC filings. A search, not a complete review of filings.
- Excluded from the ranking: WuXi AppTec (contract research and manufacturing, not a device maker); Johnson & Johnson and Thermo Fisher (not classified as medical-device companies by either source). Medline (supplies) would rank about 9th.