FDA.reportPublic FDA data

PENTAX of America, Inc.

Matched from indexed company URL: PENTAX CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25188971000080301PENTAX of America, Inc.1Y2026-01-013 Paragon Drive MONTVALE NJ US 07645
30124147603012414760Pentax Medical1N2026-01-016715 Millcreek Drive, Unit 1 Mississauga Ontario CA L5N 5V2
30146052023014605202PENTAX MEDICAL (PENANG) SDN. BHD.1N2026-01-01Plot 554, Lorong Perusahaan 4 Prai Free Trade Zone Penang Pulau Pinang MY 13600
30087801343008780134Pentax of America, Inc.1N2020-04-25303 Convention Way Ste 1 Ste 3 Redwood City CA US 94063
30143456573014345657PENTAX AOHUA MEDICAL TECHNOLOGIES COMPANY, LTD (PTAH)1N2020-04-25EAST OF 3RD FLOOR, BLOCK C, BUILDING 1 NO. 5 SHENWANG ROAD SHANGHAI Shanghai CN 210108

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
856421773417526K990240ELECTROGLOTTOGRAPHKLX1999-03-11
856421777528058K983017MODIFICATION TO SYSTEM 83 PLUSNVE1998-09-22
856421031382075K963056ED-3410, VIDEO DUODENOSCOPEFDT1996-10-10
856421615715906K962897EG-3400, VIDEO GASTROSCOPEFDS1996-10-04
2745341615715906K962897EG-3400, VIDEO GASTROSCOPEFDS1996-10-04
856422064306753K961570KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)FDF1996-06-24
856421138471909K961564EG-2940, VIDEO GASTROSCOPEFDS1996-07-09
2745341138471909K961564EG-2940, VIDEO GASTROSCOPEFDS1996-07-09
856421966535282K961563EC-384OTL, VIDEO COLONSCOPEFDF1996-06-19
856421298953885K9547987100 SWALLOWING WORKSTATIONKLA1996-06-04
856421511582594K953286FCP-9P, FIBER CHOLEDOCHOSCOPEFBN1995-11-03
856421174420712K951579EC-3800TL, VIDEO COLONOSCOPEFDF1996-03-21
856421694521352K951577ES-3800, VIDEO SIGMOIDOSCOPEFAM1996-03-21
2745341694521352K951577ES-3800, VIDEO SIGMOIDOSCOPEFAM1996-03-21
856421997900361K951574EC-3800L, VIDEO COLONOSCOPEFDF1996-03-21
856421272415962K951199FB-18X, FIBER BRONCHOSCOPEEOQ1995-04-10
2745341272415962K951199FB-18X, FIBER BRONCHOSCOPEEOQ1995-04-10
856421010620828K951198FE-34TH, FIBER ESOPHAGOSCOPEGCL1995-05-30
856421375126373K951196FNL-10P, FIBER NASOPARHYNGOSCOPEEOB1995-04-07
2745341375126373K951196FNL-10P, FIBER NASOPARHYNGOSCOPEEOB1995-04-07
856421865982857K944656OPTUS SINUSCOPES AND ACCESSORIESEOB1995-01-26
856421038708067K934920VB-1830/VB-1530, VIDEO BRONCHOSCOPEEOQ1994-01-26
856421734210357K934918EPM-3300 VIDEO PROCESSORFET1994-02-07
856421549264138K921707PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2EOB1992-07-01
2745341549264138K921707PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2EOB1992-07-01
856421426264415K9212859105 RIGID TELESCOPIC ENDOSCOPEEQL1992-05-28
856421861498353K921184RLS 9100 RHINO-LARYNGEAL STROBOSCOPEEQL1992-05-28
856421112760019K914145DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPESFEB1994-02-22
856421215261651K914106PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10PFGB1992-01-10
856421153279706K914008PENTAX CYSTOFIBERSCOPE, MODEL FCY-15PFAJ1992-01-10
856421685312017K884836UNIVERSAL GENERATOR IRRIGATOR MODEL UGI-3000GEI1988-12-06
856421395446038K871712MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.NVE1988-01-14
856421475048779K850020PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23FDS1985-07-09
856421661752748K832458AUTOMATIC ENDOSCOPENVE1983-10-20
856421872974021K771739PENTAX LH-150F LIGHT SOURCEFCW1977-09-30
2745341894616136K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)FDS2025-12-16
2745341532680760K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)FDS2024-12-06
2745341418477107K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPEA2023-07-28
2745341811550355K223072PENTAX Medical Video Esophagoscope EE17-J10EOX2022-12-02
2745341494557354K210177PENTAX Medical Video Upper GI Scopes EG17-J10FDS2021-10-20
2745341394689707K202365Pentax Medical Video Duodenoscope ED32-i10FDT2021-04-01
2745341699144776K200678PENTAX Medical Video Bronchoscope EB-J10 SeriesEOQ2020-07-30
2745341955357140K200090PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)ODG2020-07-23
856421550440278K193036C2 CryoBalloon EndoGripOCX2019-11-22
2224501550440278K193036C2 CryoBalloon EndoGripOCX2019-11-22
856421949062388K192245Pentax Medical Video Duodenoscope ED34-i10T2FDT2019-11-15
2745341949062388K192245Pentax Medical Video Duodenoscope ED34-i10T2FDT2019-11-15
856421910273385K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPEA2019-11-08
856421768635636K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cLPEA2019-12-20
2745341768635636K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cLPEA2019-12-20
856422018893502K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon CartridgeGEH2019-05-31
2224502018893502K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon CartridgeGEH2019-05-31
856421967294821K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UEOQ2019-09-06
2745341967294821K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UEOQ2019-09-06
856421576165984K182004PENTAX Medical Endoscopic Ultrasound SystemODG2018-08-21
2745341576165984K182004PENTAX Medical Endoscopic Ultrasound SystemODG2018-08-21
856421894496949K181509Endorate Valve SetsOCX2018-07-06
856421720303083K180292PENTAX Video Upper G.I. Scope EG34-i10FDS2018-10-12
2745341720303083K180292PENTAX Video Upper G.I. Scope EG34-i10FDS2018-10-12
856421718832838K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesFDF2018-10-26
2745341718832838K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesFDF2018-10-26
856421389825331K172156PENTAX Medical EPK-3000 Video Imaging SystemEOB2018-04-05
2745341389825331K172156PENTAX Medical EPK-3000 Video Imaging SystemEOB2018-04-05
856422071264068K171011PENTAX Medical VIVIDEO ENT Videoscope SolutionEOB2018-07-18
2745342071264068K171011PENTAX Medical VIVIDEO ENT Videoscope SolutionEOB2018-07-18
856421892562837K163684C2 CryoBalloon Ablation SystemGEH2018-01-23
2224501892562837K163684C2 CryoBalloon Ablation SystemGEH2018-01-23
856422012847989K163614PENTAX Medical ED34-i10T, Video DuodenoscopeFDT2017-09-20
2745342012847989K163614PENTAX Medical ED34-i10T, Video DuodenoscopeFDT2017-09-20
856421063557348K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound ScannerODG2017-04-13
2745341063557348K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound ScannerODG2017-04-13
856421262411964K162151PENTAX Medical ENT Video Imaging SystemEOB2017-04-20
2745341262411964K162151PENTAX Medical ENT Video Imaging SystemEOB2017-04-20
856421555465001K161773CapsoCam Plus (SV-3) Capsule Endoscope SystemNEZ2016-10-21
856421369427023K161228Radiance Ultra Series ZeroWire EmbeddedGCJ2016-05-26
856421185029424K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopeFDT2018-02-07
856421825296195K161202C2 Cryoballoon Ablation SystemGEH2017-01-05
2224501825296195K161202C2 Cryoballoon Ablation SystemGEH2017-01-05
856422026950313K160994C2 CryoBalloon Focal Pear CatheterGEH2016-05-19
2224502026950313K160994C2 CryoBalloon Focal Pear CatheterGEH2016-05-19
856421249898195K153563AirFit F20BZD2016-05-13
856421762870829K153541Coldplay CryoBalloon® Ablation SystemGEH2016-01-07
2224501762870829K153541Coldplay CryoBalloon® Ablation SystemGEH2016-01-07
856421419934033K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemGEH2016-04-13
2224501419934033K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemGEH2016-04-13
856421057970562K152189EVOTECH ECRFEB2016-07-20
856421451359600K152140Boa Endoscopic ValveOCX2015-10-13
2224501451359600K152140Boa Endoscopic ValveOCX2015-10-13
856421342155607K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemGEH2015-07-07
2224501342155607K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemGEH2015-07-07
856421725645045K150618PENTAX Medical EPK-i7010 Video Processor with GI FamilyPEA2015-11-24
856422004758176K150083Sidecar External Working ChannelFED2015-04-14
2224502004758176K150083Sidecar External Working ChannelFED2015-04-14
856421679839953K142368NOBLUS DIAGNOSTIC ULTRASOUND SCANNERIYN2015-01-14
856421424760094K134016ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNERIYN2014-03-28
856421540560731K131946ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUSEOQ2014-04-25
2745341540560731K131946ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUSEOQ2014-04-25
856422048340769K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)FDS2014-04-10
2745342048340769K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)FDS2014-04-10
856421874947943K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)FDF2014-04-09
2745341874947943K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)FDF2014-04-09
856421179543353K131523CRYOBALLOON FOCAL ABLATION SYSTEMGEH2013-08-22
2224501179543353K131523CRYOBALLOON FOCAL ABLATION SYSTEMGEH2013-08-22
856421257365922K131078SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMMED2013-07-05
856421319240169K131028PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)EOQ2014-04-10
2745341319240169K131028PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)EOQ2014-04-10
856421541504641K130247PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSODG2013-03-20
2745341541504641K130247PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSODG2013-03-20
856421424250724K130206PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSODG2013-03-20
2745341424250724K130206PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSODG2013-03-20
856421738778854K122470PENTAX EPK-I5010 VIDEO PROCESSORPEA2013-04-10
856421245750883K113310ENDOGATER AVANTAGE CO2 INSUFFLATORFCX2012-06-20
856422003771993K113119ENDOGATOR ADVANTAGE IRRIGATION PUMPOCX2012-04-27
856421955422233K101825CRYOBALLOON ABLATION SYSTEMGEH2010-09-29
2224501955422233K101825CRYOBALLOON ABLATION SYSTEMGEH2010-09-29
856421942535697K093792LED LIGHT SOURCEFCW2010-03-18
856422029843323K093718ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003FCY2010-02-22
856421340171081K093665ENDO SMARTCAPFAJ2009-12-15
856421957095440K093466HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUSIYO2010-06-17
856421171946595K092429ENDOGATORFEQ2009-11-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEH182019-05-31
FDS122025-12-16
EOQ112020-07-30
ODG112020-07-23
EOB112018-07-18
FDF82018-10-26
FDT72021-04-01
OCX72019-11-22
PEA62023-07-28
FEB32016-07-20
IYN32015-01-14
NVE31998-09-22
FED22015-04-14
FCW22010-03-18
FAJ22009-12-15
FAM21996-03-21
EQL21992-05-28
EOX12022-12-02
NEZ12016-10-21
GCJ12016-05-26
BZD12016-05-13
MED12013-07-05
FCX12012-06-20
IYO12010-06-17
FCY12010-02-22
FEQ12009-11-19
NZA12004-12-17
ITX12004-06-09
KLX11999-03-11
KLA11996-06-04
FBN11995-11-03
GCL11995-05-30
FET11994-02-07
FGB11992-01-10
GEI11988-12-06

PMN#

132 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next