Pentax Medical, A Division of Pentax of America, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Pentax Medical, A Division of Pentax of America, Inc. - FDA 510(k) Cl...
Recent clearances: C2 CryoBalloon EndoGrip, C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
2
Total
2
Cleared
0
Denied
Pentax Medical, A Division of Pentax of America, Inc. has 2 FDA 510(k) cleared medical devices. Based in Redwood, Ca, US.
Historical record: 2 cleared submissions from 2019 to 2019. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Pentax Medical, A Division of Pentax of America, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Pentax Medical, A Division of Pentax of America, Inc.
2 devices