Medical Device Manufacturer · US , Minneapolis , MN

Ultimed Incorporated - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2015

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ultimed Incorporated General Hospital ✕

2 devices

1-2 of 2

Cleared Dec 16, 2021

UltiCare Disposable Pen Needles

General Hospital · 58d

Cleared Feb 09, 2015

ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE

General Hospital · 301d

Data Source

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

Last updated: May 23, 2026