Navigators

FDA Device Navigator

Search and monitor FDA-approved medical devices across 510(k) clearances, PMA approvals, recalls, the UDI database, and adverse event reports. Track new approvals in real time, analyze indications for use, and monitor competitive device activity. Polify integrates directly with the openFDA API to deliver current device intelligence alongside payer coverage data.

FDA

FDA Device Navigator

Search and monitor FDA-approved medical devices, track new approvals, and analyze indications for use

Filters
Search by device name, manufacturer, or product code...
Found 7 results
NeuroCath Neurovascular Catheter
510kClass II

A microcatheter designed for use in the peripheral, coronary, and neurovascular system for the infusion of diagnostic agents and therapeutic agents.

Decision: 09-19-2022Becton Dickinson#Product Code: DQYNew Approval
HeartValve Transcatheter Aortic Valve
PMAClass III

A transcatheter aortic valve replacement (TAVR) system for the treatment of severe aortic stenosis in patients at high or extreme risk for surgical valve replacement.

Decision: 09-09-2022Boston Scientific#Product Code: NPTNew Approval
DermaHeal Wound Care System
510kClass II

An advanced wound care system that uses negative pressure to promote wound healing for acute and chronic wounds.

Decision: 08-14-2022Johnson & Johnson#Product Code: OMPNew Approval
BoneGraft Synthetic Bone Void Filler
510kClass II

A synthetic bone graft substitute intended for use as a bone void filler for bony defects of the skeletal system.

Decision: 07-29-2022Stryker Corporation#Product Code: MQV
SleepWell CPAP Device
510kClass II

A continuous positive airway pressure (CPAP) device for the treatment of obstructive sleep apnea.

Decision: 07-24-2022Philips Healthcare#Product Code: BZDNew Approval
OrthoFlex Knee Replacement System
510kClass II

A total knee replacement system designed to restore function to the knee for patients suffering from severe knee pain and disability due to arthritis, rheumatoid arthritis, or traumatic injury.

Decision: 07-09-2022Stryker Corporation#Product Code: JWHNew Approval
DiabetesGuard Continuous Glucose Monitor
PMAClass III

A continuous glucose monitoring system for the management of diabetes, providing real-time glucose measurements and alerts for high and low glucose levels.

Decision: 06-14-2022Abbott Laboratories#Product Code: MDSNew Approval

510(k) and PMA Tracking

Monitor 510(k) clearances and PMA approvals as they are issued. Filter by device class, manufacturer, product code, and decision date to track competitive approvals and identify new market entrants.

Recall and Adverse Event Monitoring

Stay informed on FDA recalls and adverse event reports for devices in your competitive landscape. Set up monitoring alerts to receive notifications when new recalls or MDR reports are filed.

UDI Database Search

Search the FDA Unique Device Identifier database to look up device identifiers, labeler information, and device descriptions. Cross-reference UDI data with payer coverage policies for comprehensive device intelligence.