Medical Device Manufacturer · US , Walker , MI

Gazelle Corp. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1982

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gazelle Corp. Ophthalmic ✕

2 devices

1-2 of 2

Cleared Jan 03, 1985

MAGNIFYING SPECTACLES W/PLASTIC LENSES

Ophthalmic · 30d

Cleared Jun 14, 1982

PLASTIC OR GLASS MAGNIFIER

Ophthalmic · 125d

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 28, 2026