Medical Device Manufacturer · IL , Binyamina

Pollogen, Ltd. - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 2011

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Pollogen, Ltd. Neurology ✕

2 devices

1-2 of 2

Regulatory consultants 510(k) submission support ecosystem

Regulatory Technology Services, LLC

BioVision , Ltd.

A. Stein Regulatory Affairs Consulting Company , Ltd.

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026