Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

46 results for "Pentax of America, Inc."
1–24 of 46
Cleared Dec 16, 2025
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family)
K251256 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 237d
Cleared Jun 03, 2025
PENTAX Medical Video Processor (EPK-i8020c)
K251127 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 53d
Cleared Jan 03, 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
K242110 · FDF
Pentax of America, Inc.
Gastroenterology & Urology · 168d
Cleared Dec 06, 2024
PENTAX Medical Video Upper GI Scope (EG27-i20c)
K241213 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 220d
Cleared Aug 01, 2024
PENTAX Medical Video Duodenoscope (ED34-i10T2s)
K233942 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 231d
Cleared Jul 24, 2024
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
K240457 · GEH
Pentax of America, Inc.
General & Plastic Surgery · 159d
Cleared Jan 18, 2024
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope...
K232860 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 125d
Cleared Jan 12, 2024
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single...
K231970 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 193d
Cleared Dec 01, 2023
PENTAX Medical Gas/Water Feeding Valve OE-B14
K232249 · ODC
Pentax of America, Inc.
Gastroenterology & Urology · 126d
Cleared Jul 28, 2023
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI...
K231249 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 88d
Cleared Dec 21, 2022
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
K213235 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 447d
Cleared Dec 02, 2022
PENTAX Medical Video Esophagoscope EE17-J10
K223072 · EOX
Pentax of America, Inc.
Ear, Nose, Throat · 63d
Cleared Nov 16, 2022
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX...
K220465 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 272d
Cleared Nov 29, 2021
C2 CryoBalloon Ablation System
K212814 · GEH
Pentax of America, Inc.
General & Plastic Surgery · 87d
Cleared Oct 21, 2021
PENTAX Medical Video Bronchoscope EB11-J10
K210928 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 206d
Cleared Oct 20, 2021
PENTAX Medical Video Upper GI Scopes EG17-J10
K210177 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 271d
Cleared Oct 01, 2021
PENTAX Medical Auto Leakage Tester SHA-P6
K212201 · PCV
Pentax of America, Inc.
Gastroenterology & Urology · 79d
Cleared May 13, 2021
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video...
K210485 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 09, 2021
PENTAX Medical Video Duedenoscope ED34-i10T2
K210710 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 01, 2021
Pentax Medical Video Duodenoscope ED32-i10
K202365 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 225d
Cleared Dec 30, 2020
PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical...
K203166 · ODG
Pentax of America, Inc.
Gastroenterology & Urology · 68d
Cleared Nov 24, 2020
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2...
K203024 · GEH
Pentax of America, Inc.
General & Plastic Surgery · 53d
Cleared Jul 30, 2020
PENTAX Medical Video Bronchoscope EB-J10 Series
K200678 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 136d
Cleared Jul 23, 2020
PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound...
K200090 · ODG
Pentax of America, Inc.
Gastroenterology & Urology · 189d