Pentax of America, Inc. - FDA 510(k) Cleared Devices
44
Total
44
Cleared
0
Denied
Pentax of America, Inc. has 44 FDA 510(k) cleared medical devices. Based in West Cadwell, US.
Latest FDA clearance: Dec 2025. Active since 2012. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Pentax of America, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Pentax of America, Inc.
44 devices
Cleared
Dec 16, 2025
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family)
Gastroenterology & Urology
237d
Cleared
Jun 03, 2025
PENTAX Medical Video Processor (EPK-i8020c)
Gastroenterology & Urology
53d
Cleared
Jan 03, 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
Gastroenterology & Urology
168d
Cleared
Dec 06, 2024
PENTAX Medical Video Upper GI Scope (EG27-i20c)
Gastroenterology & Urology
220d
Cleared
Aug 01, 2024
PENTAX Medical Video Duodenoscope (ED34-i10T2s)
Gastroenterology & Urology
231d
Cleared
Jul 24, 2024
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
General & Plastic Surgery
159d
Cleared
Jan 18, 2024
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope...
Ear, Nose, Throat
125d
Cleared
Jan 12, 2024
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single...
Ear, Nose, Throat
193d
Cleared
Dec 01, 2023
PENTAX Medical Gas/Water Feeding Valve OE-B14
Gastroenterology & Urology
126d
Cleared
Jul 28, 2023
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI...
Gastroenterology & Urology
88d
Cleared
Dec 21, 2022
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
Ear, Nose, Throat
447d
Cleared
Dec 02, 2022
PENTAX Medical Video Esophagoscope EE17-J10
Ear, Nose, Throat
63d
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