Pentax of America, Inc. - FDA 510(k) Cleared Devices
44
Total
44
Cleared
0
Denied
FDA 510(k) cleared devices by Pentax of America, Inc. General & Plastic Surgery ✕
3 devices
Cleared
Jul 24, 2024
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
General & Plastic Surgery
159d
Cleared
Nov 29, 2021
C2 CryoBalloon Ablation System
General & Plastic Surgery
87d
Cleared
Nov 24, 2020
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2...
General & Plastic Surgery
53d