Medical Device Manufacturer · US , Buckingham , PA

Custom Ultrasonics - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1984

4

Total

4

Cleared

0

Denied

Custom Ultrasonics — FDA 510(k) Products and Clearance History General Hospital ✕

4 devices

1-4 of 4

Cleared Jan 25, 2013

General Hospital · 186d

Cleared Jan 12, 2007

SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR

General Hospital · 234d

Cleared Sep 22, 1998

MODIFICATION TO SYSTEM 83 PLUS

General Hospital · 25d

Cleared Nov 28, 1984

CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2

General Hospital · 135d