Medical Device Manufacturer · US , Centercille , MA

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

2 submissions · 2 cleared · Since 2011

Recent clearances: REPROBONE DENTAL GRAFTING MATERIAL, BIOCERAMIC ORBITAL IMPLANT, ORBTEX

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ceramisys, Ltd. Ophthalmic ✕

1 devices

1-1 of 1

Cleared Nov 02, 2011

BIOCERAMIC ORBITAL IMPLANT, ORBTEX

Ophthalmic · 247d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 15, 2026