MedDeviceGuide — IVD & Medical Device Knowledge Base
GE HealthCare FDA Device Footprint: Clearances, PMA & Recalls Guide
A data-driven regulatory profile of GE HealthCare's FDA clearances, PMA approvals, safety recalls, and offshore manufacturing hubs in India, Mexico, and Finland.
Ghana FDA Medical Device Registry: Classifications, Importers & Countries
A comprehensive, data-driven analysis of the Ghana Food and Drugs Authority (FDA) medical device registry. Explore risk classifications, local agents, and manufacturing origins.
Medtronic FDA Device Footprint: PMA, 510(k) & Recall Analysis
A data-driven regulatory profile of Medtronic's FDA clearances, massive PMA database footprint, safety recalls, and global manufacturing hubs in Memphis, Puerto Rico, Costa Rica, and India.
Philips FDA Device Footprint: Clearances, Recalls & Consent Decree
A comprehensive regulatory dossier analyzing Philips' FDA clearances, cardiovascular PMA distribution, recall history under the 2024 consent decree, and global manufacturing plants.
Siemens Healthineers FDA Footprint: 510(k), PMA & Recalls Guide
A comprehensive, data-driven regulatory dossier analyzing Siemens Healthineers' FDA 510(k) clearances, PMA approvals, recalls, and global manufacturing footprint.
Tunisia DPM AMC Medical Device Registry: Categories, Importers & Brands
A comprehensive, database-level analysis of the Tunisia DPM AMC medical device registry. Explore category volumes, leading local importers, and country-of-origin distributions.
Jordan JFDA Medical Device Registry Analysis: Importer Concentration
A comprehensive, data-driven analysis of the Jordan Food and Drug Administration (JFDA) medical device registry. Analyze applicant volumes, major distributors, and warehouse allocations.
Nigeria NAFDAC Greenbook Medical Device Registry: Licenses & Expiry Cycles
A comprehensive, data-driven analysis of the Nigeria NAFDAC Greenbook medical device registry. Explore active vs. inactive license ratios, top applicants, and the 5-year renewal cycle.
Tanzania TMDA Medical Device Registry Analysis: Data-Driven Market Insights
A data-driven analysis of the Tanzania TMDA medical device registry: registered vs. notified device ratios, top Local Technical Representatives (LTRs), and source countries.
Egypt EDA Medical Device Register Analysis: 3,959 Devices and Top Manufacturers
An in-depth analysis of 3,959 medical device registrations under the Egyptian Drug Authority, exploring top manufacturers, countries of origin, and timeline trends.
South Africa SAHPRA Medical Device Establishment Licenses (3,000 Active)
An in-depth analysis of 3,000 active SAHPRA establishment licenses, examining the balance of distributors, wholesalers, manufacturers, and municipal hubs.
Thailand FDA Medical Device Database Analysis: 43,337 Records
A comprehensive analysis of 43,337 medical device records in the Thailand FDA database, exploring active vs expired licenses, imported share, and top manufacturers.
NMPA Flight Inspections: Preparing for China's Unannounced Audits Under Order 14
A regulatory guide to China NMPA flight inspections under Decree No. 14. Understand unannounced triggers, inspector powers, and GMP readiness for manufacturers.
Ecuador ARCSA Audit: 3,939 Expired Licenses Highlight Risks Under Resolution 2026-003
An empirical audit of 3,939 expired registrations in Ecuador. Learn how to manage transition compliance risks under the new ARCSA Resolution 2026-003-DASP.
FDA Dermal Filler Approvals and Adverse Events: A 30-Year MAUDE and PMA Analysis
A comprehensive, data-driven analysis of 1,038 FDA dermal filler PMA approvals and 22,247 adverse events from the MAUDE database, detailing trends, top brands, and safety profiles.
FDA Product Code FDT: A Quantitative Audit of Duodenoscope Recalls and MAUDE Events
An empirical, data-driven safety audit of FDA product code FDT (duodenoscopes). Analyze 31 classified recalls and 3,985 adverse events from the MAUDE database.
FDA Product Code NAY: Surgical Robotics Clearance and Recall Trends
A deep dive into FDA product code NAY (computer-assisted surgical systems) using active registry data. Learn about 510(k) clearance trends and recall root causes.
Saudi SFDA MDS-G27: Digital Health and Wellness Device Regulation
A comprehensive guide to Saudi Arabia's SFDA MDS-G27 (2025) regulation on digital health. Understand the boundary between medical devices and wellness software.
South Korea MFDS Registry: Risk Class, Imports, and Sponsor Concentration
A data-driven analysis of South Korea's MFDS medical device registry. Explore risk class distributions, import vs. domestic splits, and leading sponsors.
Swissdamed Registry Analysis: 4,554 Swiss Actors and 60,611 Device Registrations
A data-driven analysis of Swissmedic's swissdamed database. We break down actor types, risk classes, legislations, and leading CH-REPs.