FDA.reportPublic FDA data

OLYMPUS Corporation of the Americas

Matched from indexed company URL: OLYMPUS CORPORATION OF THE AMERICAS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24293042429304OLYMPUS Corporation of the Americas1Y2026-01-013500 CORPORATE PKWY. CENTER VALLEY PA US 18034
24293042429304OLYMPUS Corporation of the Americas1Y2020-04-253500 CORPORATE PKWY. CENTER VALLEY PA US 18034
29512381000635022Olympus Corporation of the Americas1N2020-04-252400 RINGWOOD AVE. SAN JOSE CA US 95131

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
370241418901953K992222FLUOROPLASTIC VENTILATION TUBESETD1999-08-26
370241504456400K992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMGCX1999-08-03
370241203226324K990628GYRUS ENDOUROLOGY SYSTEMKNS1999-06-29
370241144441632K982289HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##KNS1998-08-19
370241741292573K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
370241157380479K980492AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)FFK1998-11-17
370241251323062K974311VOCOM (VOCAL CORD MEDIALIZATION) IMPLANTKHJ1998-03-04
370241381787491K973286ENT IRRIGATING PUMP (70327700)ERL1997-09-29
370241870780700K971328OLYMPUS CD-6C-1 COAGULATION ELECTRODEFFE1997-07-01
370241678727630K964334EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)GCJ1996-12-09
370242049632142K963033BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIESEOQ1996-09-09
370241980941795K962564RICHARDS TOTAL/PARTIAL PROSTHESISETB1997-01-22
370241935894426K954451EVIS 140 SYSTEMFET1996-03-29
370241698299502K953162OLYMPUS HIGH FLOW INSUFFLATION UNITHIF1995-12-19
370241377597197K953096ESSENTIAL SHAVER SYSTEMEQJ1995-07-28
370241234230659K952892OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)ITX1996-02-12
89211361069789K952888OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWSLMB1995-09-18
370241816954597K951445OLYMPUS FD-5 HOT BIOPSY FORCEPSKGE1995-05-03
370241737035684K950984HAPES MALLEABLE INCUS STAPESETB1995-03-15
370241528437725K944912OLYMPUS NBD TUBESFGE1995-06-13
370241209495714K941743CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMPHIG1995-04-19
370241232251632K940133THE EXPANDACELL EAR PACKLRD1994-05-23
370241707159792K936048LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)FST1994-03-10
370241503237657K935235ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERYGCM1995-03-23
89211589438478K934889OLYMPUS IMAGEMANAGER SYSTEMLMB1994-01-28
89212051319369K934888OLYMPUS IMAGEMANAGERSYSTEMLMB1994-01-25
370241726924341K934733STIMULATING SURGICAL INSTRUMENTSETN1994-07-20
370241269919466K934432OTOVIEW ENDOSCOPY SYSTEMEWA1994-04-25
370241238942717K921433ATTIC DEFECT PLATEETC1993-03-18
370241146961321K914496SCLEROTHERAPY NEEDLEFBK1991-12-05
370241287573643K912120URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPEFBN1991-08-07
370241872470461K911904MODELS UES-10 & PSD-10GEI1991-07-26
370241990471800K904797SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)FBO1991-03-05
370241373801256K903529BML SERIESLQC1991-01-23
370241292761631K902737BC BRUSHESFDX1990-08-24
370241159345750K902734PR CANNULASFGE1990-08-22
370241820862922K893491MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300FST1989-06-22
370241003638438K891451OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPEHIH1989-10-02
370241645830342K874467SET, ADMINISTRATION INTRAVASCULARFPA1988-01-06
370241924923086K873367OLYMPUS LUS ULTRASONIC LITHOTRIPTERFEO1987-11-30
370241449158482K864443EGG-TOP TORP AND EGG-TOP PORPETA1987-02-02
370242062069830K852980OCS-2 COLPOSCOPEHEX1985-10-23
370241009803960K850978OLYMPUS LF-1 INTUBATION SCOPECAL1985-05-23
370241807320735K781574PLASTI-PORE SEPTAL BUTTONFZE1978-09-27
370241419849160K780586MICROCLIP, WILLIAMSGDW1978-05-16
370241693174645K760435PISTON, PLATINUM TEFLON, OTOLOGY IMPLANTETB1976-09-27
89211194771277K142680ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHTNEZ2015-02-08
89211080521489K142525PK Lap LoopHIN2014-11-21
89211784040013K141225ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORDGEI2014-08-12
89211490028813K140624HICURA HAND INSTRUMENTSGEI2014-12-10
89211373608881K132703THUNDERBEATGEI2014-05-19
89211338416565K123601SINGLE USE REPOSITIONABLE CLIPPKL2013-04-29
89211933082526K123319GYRUS ACMI BICOAG HEMOSTASIS PROBEKNS2012-12-14
89211295224128K122505SINGLE USE PRELOADED SPHINCTEROTOME VKNS2013-04-11
89211643540313K122180HIGH FLOW INSUFFLANTION UNITHIF2012-11-13
89211667381378K111202SURGICAL TISSUE MANAGEMENT SYSTEMGEI2012-01-20
89211705254622K103478SINGLE USE BILIARY DRAINAGE STENT VFGE2011-02-24
89211969524275K103264ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PROFEB2011-02-23
89212010542079K103032ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJGEI2011-01-14
89211954507141K102781RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDSFAS2011-01-11
89211713453664K093106ENDOSCOPE REPROCESSOR OER-PROFEB2010-02-12
370241926258741K063786ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2FCX2007-03-05
370241625874247K051551SMALL INTESTINAL VIDEOSCOPE SYSTEMKNT2005-06-28
370241229245218K042516OTOMIMIXNEA2004-11-08
370241136188117K041285GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)GEI2004-09-10
370241148053482K031078EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPSGEI2003-05-16
370241072036765K030935BERKELEY V-10 VACUUM CURETTAGE SYSTEMHHI2003-06-23
370242066473184K030343DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACEHAW2003-05-02
370241720204812K021595GYRUS ENT NERVE STIMULATORETN2002-10-24
370241618865274K021166ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BRFDC2002-05-09
370241582711419K020778GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420GEI2002-05-28
370242017177886K020594DIEGO POWERED DISSECTOR AND DRILL SYSTEMERL2002-03-08
370241283301662K013165USA SERIES LAPAROSCOPESGCJ2002-01-18
370241480176846K012073OLYMPUS SPRAY CATHETER PW-6C-1EOQ2001-08-10
370241680498477K012018BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910GEI2002-07-16
370241604471307K002749ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13DFDF2000-12-04
370242049637381K002702NEUROTOLOGY DRAPE, MODEL TBDKKX2000-10-26
370241044950702K001241EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/IFDF2000-05-09
370241886796151K001203OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACTITX2000-05-26
370241837211166K000533VOCOM IMPLANT- 8MMMIX2000-03-01
370241119596658K000256CAP PORP, CAP TORPETB2000-02-11
370241452278660DEN020003RETROXNIX2002-08-20
89212050822157

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI102014-12-10
KNS42013-04-11
ETB42000-02-11
FGE32011-02-24
LMB31995-09-18
HIF22012-11-13
FEB22011-02-23
ETN22002-10-24
ERL22002-03-08
GCJ22002-01-18
EOQ22001-08-10
FDF22000-12-04
ITX22000-05-26
FST21994-03-10
NEZ12015-02-08
HIN12014-11-21
PKL12013-04-29
FAS12011-01-11
FCX12007-03-05
KNT12005-06-28
NEA12004-11-08
HHI12003-06-23
HAW12003-05-02
NIX12002-08-20
FDC12002-05-09
KKX12000-10-26
MIX12000-03-01
ETD11999-08-26
GCX11999-08-03
FFK11998-11-17
EOB11998-08-13
KHJ11998-03-04
FFE11997-07-01
FET11996-03-29
EQJ11995-07-28
KGE11995-05-03
HIG11995-04-19
GCM11995-03-23
LRD11994-05-23
EWA11994-04-25

PMN#