Easily identify predicate devices that can be used to bring a new device to market through the FDA’s 510(k) application process
Helping manufacturers bring a new device to market or monitor their existing portfolio of devices requires access to transparent, comprehensive safety and quality data. Yet, accessing and evaluating this data can be a laborious and time-consuming process, limiting the number of projects that a consultant can manage. Now this research can be done in just a fraction of the time with Navigator for Medical Devices. Easily search and analyze FDA clearances, products, adverse event reports, guidance documents and more all at your fingertips. In just a few clicks you can quickly pin-point predicate candidates, understand competitors and monitor future safety events.
Gain medical device insights today with Navigator for
Instant access to search by FDA Product Code, Manufacturer Name, Intended Use, and more
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At a glance, Navigator can help:
Explore product clearances
of competitive devices
Trust that you have access to clean data to
understand reported product problems,
adverse event reports, recalls and their causes
Discover FDA product codes
Identify the best predicate device – search 510(k)s by intended use, indication for use, and more
Seamlessly identify applicable
Did you know? Find Predicates and Successors
Free Trial of Navigator
Access to search by FDA Product Code, Manufacturer Name, Intended Use, and more:
- Product Search: search by K Number, PMA Number and Device Type with advanced filtering to refine results.
- Clearance Search: quickly search by K Number, De Novos Number, Device Description, or Intended Use/Indication for Use, a feature only found in Navigator.
- Adverse Events: search by Report Number, MDR Report Key or Initial Event Date with additional filters to refine results sets.
- Watchlists: monitor new events for selected products or separately, for selected clearances.
Understand the trends for medical safety and quality—then use that knowledge to better inform risk management, product design, market research, post-market surveillance and regulatory intelligence.