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Search the Releasable 510 (k) Database | FDA You can search the releasable 510 (k) database by Panel, 510 (k) number, Product code or Device name A search query will produce information from the database in the following format:
Premarket Notifications (510 (k)s) - Catalog This database of releasable 510 (k)s can be searched by 510 (k) number, applicant, device name or FDA product code Summaries of safety and effectiveness information is available via the web interface for more recent records
FDA 510 (k) Database: What Most Device Makers Get Wrong Visit the FDA 510 (k) database, enter a relevant keyword—such as a device name or manufacturer—and review the results Each entry provides summary information, classification details, and a brief overview of the FDA’s decision
FDA 510 (k) Applications Database This website contains over 132,000 FDA 510 (k) applications and decisions collected since May, 1976 from the U S Food and Drug Administration's publicly available databases of FDA Device Approvals and Clearances
FDA 510k database - Kobridge The 510 (k) database is a comprehensive listing of Class I, Class II, and III medical devices that have been cleared for commercial distribution in the United States by demonstrating substantial equivalence to a predicate device already on the market
510 (K) Premarket Notification - Food and Drug Administration A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device
510 (k) Clearances | FDA Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance
The FDA 510 (k) Database: Key Insights for Medical Devices In this article, we will delve deeper into the structure, significance, and practical applications of the FDA 510 (k) database We will explore the specific procedures involved in the 510 (k) clearance process and highlight how different types of devices are categorized
Navigating US FDA 510 (k) Database: A Step-by-step Guide The US FDA 510 (k) database is a centralized record of all US FDA 510 (k) submissions This database serves as a public resource to verify device clearances and track regulatory compliance