Medical Device Manufacturer · US , Dever , CO

Certa Dose, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2017

Recent clearances: Certa Dose Pediatric Midazolam 5mg/mL IM Syringe, Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Certa Dose, Inc. General Hospital ✕

2 devices

1-2 of 2

Cleared Nov 07, 2018

Certa Dose Pediatric Midazolam 5mg/mL IM Syringe

General Hospital · 237d

Cleared Jan 19, 2017

Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

General Hospital · 324d

Data Source

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

Last updated: Jun 09, 2026