PENTAX Of America, Inc

FDA Filings

This page includes the latest FDA filings for PENTAX Of America, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
PENTAX Of America, Inc.
Pentax Medical Video Duodenoscope ED34-i10T22019-11-15
PENTAX Of America, Inc.
PENTAX Medical Video Upper GI Scopes (EG Family)2019-11-12
PENTAX Of America, Inc.
PENTAX Medical EPK-i7010 And PENTAX EPK-i5010 Video Processors With GI Family2019-11-08
PENTAX Of America, Inc.
PENTAX Medical ENT Video Imaging System2019-06-12
PENTAX Of America, Inc.
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS And HI VISION Preirus2019-05-23
PENTAX Of America, Inc.
PENTAX Medical Endoscopic Ultrasound System2018-08-21
PENTAX Of America, Inc.
PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope2018-07-09
PENTAX Of America, Inc.
PENTAX Medical EPK-i7010 Video Processor With EB Family Of Scopes2018-07-03
PENTAX Of America, Inc.
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, And PENTAX Medical Ultrasond Video Bronchoscope2018-01-19
PENTAX OF AMERICA, INC.
PENTAX Medical ENT Video Imaging System2017-04-20
PENTAX Of America, Inc.
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) With EPK-i5010 Video Processor And HI VISION Preirus Ultrasound Scanner2017-04-13
PENTAX OF AMERICA, INC.
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS2013-03-20
PENTAX OF AMERICA, INC.
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS2013-03-20

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
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PENTAX OF AMERICA, INC.2019-11-27
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
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PENTAX OF AMERICA, INC.2019-11-08
n/a
PENTAX OF AMERICA, INC.2019-11-08

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