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Pentax of America Inc

10 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Pentax Medical Video Processor; Model Number: EPK-i8020c; recall (Z-2329-2025)Pentax of America Inc2025-08-15
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a vide recall (Z-1236-2025)Pentax of America Inc2025-02-26
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a vi recall (Z-1237-2025)Pentax of America Inc2025-02-26
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monito recall (Z-1238-2025)Pentax of America Inc2025-02-26
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), recall (Z-0292-2021)Pentax of America Inc2020-10-23
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with recall (Z-0293-2021)Pentax of America Inc2020-10-23
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cr recall (Z-2256-2018)PENTAX of America Inc2018-06-05
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) recall (Z-0643-2018)Pentax of America Inc2018-02-20
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including l recall (Z-0636-2017)Pentax of America Inc2016-11-19
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including l recall (Z-0318-2017)Pentax of America Inc2016-10-26

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Every clearance here is in the API, with alerts when new ones post.