FDA.reportPublic FDA data

OLYMPUS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24293042429304OLYMPUS Corporation of the Americas1Y2026-01-013500 CORPORATE PKWY. CENTER VALLEY PA US 18034
80100473002807795OLYMPUS MEDICAL SYSTEMS CORP.1N2026-01-012951 ISHIKAWA-CHO HACHIOJI-SHI T?ky? JP 192-8507
96107733002807798OLYMPUS WINTER & IBE GMBH1N2026-01-01KUEHNSTRASSE 61 HAMBURG DE 22045
30080404023008040402Olympus Vietnam Co. Ltd.1N2026-01-018 Street, Long Thanh Industrial Zone An Phuoc Commune Dong Nai City ??ng Nai VN 810000
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
30079602823007960282Olympus Medical Products Czech1N2020-04-25Ul Telickova 457/29 Prerov II Predmosti Prerov CZ 75124

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04953170332890CONNECTING TUBE - MAJ-1969+1(800)401-1086xx@xx.xx
04953170339301EVIS EXERA II BRONCHOVIDEOSCOPE - BF-Q180 VIDEOSCOPE 5.1MM DIA 2.0MM CH+1(800)401-1086xx@xx.xx
04953170339349EVIS EXERA II BRONCHOVIDEOSCOPE - BF-1TQ180 VIDEOSCOPE 6.2MM DIA 2.8MM CH+1(800)401-1086xx@xx.xx
04953170339905EVIS EXERA II COLONOVIDEOSCOPE - "PCF-H180AL EVIS EXERA II COLONOSCOPE"+1(800)401-1086xx@xx.xx
04953170340246VISERA TRACHEAL INTUBATION VIDEOSCOPE - LF-V TRACHEAL INTUBATION VIDEO SCOPE+1(800)401-1086xx@xx.xx
04953170350474CONNECTING TUBE - MAJ-2124+1(800)401-1086xx@xx.xx
04953170353994GAS CAP - MAJ-2131+1(800)401-1086xx@xx.xx
04953170395581EVIS EXERA III BRONCHOFIBERVIDEOSCOPE - OLYMPUS BF-MP190F+1(800)401-1086xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3223441957900258K994418VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH2000-01-24
234831285971246K993041OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENTFAJ2000-03-30
3223441988984750K992901GYNECARE VERSAPOINT G-VAP ELECTRODEHIH2000-01-18
370241418901953K992222FLUOROPLASTIC VENTILATION TUBESETD1999-08-26
3223441971835596K992141OLYMPUS WORKING ELEMENT FOR PROBESFDC1999-09-29
370241504456400K992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMGCX1999-08-03
370241203226324K990628GYRUS ENDOUROLOGY SYSTEMKNS1999-06-29
3223441529946676K990237TROCAR SYSTEM ACCORDING TO HASSONGCJ1999-07-12
3223441562382610K984417BIPOLAR GRASPING FORCEPS BIQ+GEI1999-02-24
234831629228660K984358OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597FDS1999-09-17
1100741629228660K984358OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597FDS1999-09-17
234831802125887K984255OLYMPUS HX-20 SERIES LIGATING DEVICEMND1999-01-12
3223441874874457K983811UNIPOLAR OPTICAL BIOPSY FORCEPSKGE1998-12-24
3223441144881466K982738VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH1999-03-01
234831496990229K982734OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USEODG1998-10-05
234831914812568K982733OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USEITX1998-10-28
234831769478690K982610OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)ITX1998-11-16
234831487729013K982323OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USEITX1998-12-11
234831059774671K982289HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##KNS1998-08-19
370241144441632K982289HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##KNS1998-08-19
234831067586029K981993OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHAODA1998-08-21
370241741292573K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
234831529361886K981543OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENTEOQ1998-06-08
370241157380479K980492AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)FFK1998-11-17
234831274645834K980465OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERSFDT1998-04-21
1100741274645834K980465OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERSFDT1998-04-21
370241251323062K974311VOCOM (VOCAL CORD MEDIALIZATION) IMPLANTKHJ1998-03-04
370241381787491K973286ENT IRRIGATING PUMP (70327700)ERL1997-09-29
234831887963430K971660OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENTFDS1997-07-25
234831710209735K971416OLYMPUS OES OTV-S5C VIDEO SYSTEMFET1997-07-16
370241870780700K971328OLYMPUS CD-6C-1 COAGULATION ELECTRODEFFE1997-07-01
370241678727630K964334EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)GCJ1996-12-09
234831036958696K963184OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEMGCJ1996-12-31
234831894263317K963033BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIESEOQ1996-09-09
370242049632142K963033BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIESEOQ1996-09-09
234831034578318K962925OLYMPUS B-5/B-7 SERIESBALLOON CATHETERFGE1996-10-25
234831918733808K962901OLYMPUS B5-2C/B7-2C BALLOON CATHETEREOQ1996-08-20
370241980941795K962564RICHARDS TOTAL/PARTIAL PROSTHESISETB1997-01-22
234831604646543K962555OLYMPUS FB SERIES BIOPSY FORCEPSEOQ1996-07-30
234831034547630K962533OLYPUS FG SERIES GRASPING FORCEPSEOQ1996-08-09
234831246031844K962485OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)EOQ1996-08-20
3223441467102918K962482SCUBA SYSTEMHIH1996-11-01
234831016807912K962387OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)FFL1996-07-31
234831025845838K962378OLYMPUS FG-45/46-1 GRASPING FORCEPSEOQ1996-08-02
234831972726372K961048OLYMPUS MH-246R BALLOON SHEATHODG1996-09-16
234831584646076K955650OLYMPUS SD SERIES SNARESFDI1996-03-29
1100741584646076K955650OLYMPUS SD SERIES SNARESFDI1996-03-29
3223441573576785K955623OLYMPUS BIPOLAR FORCEPSGEI1996-02-13
234831506448262K955404OTV-S5 OES VIDEO SYSTEMGCJ1996-02-01
234831618400520K955403OES LAPARO-THORACO VIDEOSCOPE TYPE VHET1996-03-11
234831718085998K955247OLYMPUS KD SERIES SPHINCTEROTOMEKNS1996-04-30
234831143645266K955065OLYMPUS FB SERIES BIOPSY FORCEPSFCL1996-01-24
1100741143645266K955065OLYMPUS FB SERIES BIOPSY FORCEPSFCL1996-01-24
234831981659596K955063OLYMPUS BASKET GRASPERSOCZ1996-01-22
234831453327146K955051OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPSOCZ1996-01-18
234831921593243K955049OLYMPUS FG-45/46-1 GRASPING FORCEPSFFL1995-12-15
3223441558986347K954488ROLLER ELECTRODEHIH1997-03-06
1103721988414566K954488ROLLER ELECTRODEHIH1997-03-06
234831060803140K954451EVIS 140 SYSTEMFET1996-03-29
370241935894426K954451EVIS 140 SYSTEMFET1996-03-29
370241698299502K953162OLYMPUS HIGH FLOW INSUFFLATION UNITHIF1995-12-19
234831931741722K953162OLYMPUS HIGH FLOW INSUFFLATION UNITHIF1995-12-19
370241377597197K953096ESSENTIAL SHAVER SYSTEMEQJ1995-07-28
370241234230659K952892OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)ITX1996-02-12
234831738942144K952892OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)ITX1996-02-12
89211361069789K952888OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWSLMB1995-09-18
234831576925536K951994OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTERIYO1996-04-15
1103721225631718K951863ROLLER ELECTRODEFAS1995-08-24
3223442023097842K951863ROLLER ELECTRODEFAS1995-08-24
3223441125800326K951855ULTRATHIN URETEROSCOPESFGB1995-08-16
234831669732498K951445OLYMPUS FD-5 HOT BIOPSY FORCEPSKGE1995-05-03
1100741669732498K951445OLYMPUS FD-5 HOT BIOPSY FORCEPSKGE1995-05-03
370241816954597K951445OLYMPUS FD-5 HOT BIOPSY FORCEPSKGE1995-05-03
3223441245740833K951354OLYMPUS ARTHROSCOPY SYSTEMHRX1995-06-14
370241737035684K950984HAPES MALLEABLE INCUS STAPESETB1995-03-15
234831848850859K950729OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)ODD1995-03-17
234831738324697K950636OLYMPUS DISPOSABLE BIOPSY FORCEPSEOQ1995-02-27
1100741738324697K950636OLYMPUS DISPOSABLE BIOPSY FORCEPSEOQ1995-02-27
3223441525681210K950278MINI LAPAROSCOPY FOR GENERAL SURGERYGCJ1995-02-01
234831161645951K950166OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFEKNS1995-02-22
1100741161645951K950166OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFEKNS1995-02-22
3223441657959478K950076LAPAROSCOPEGCJ1995-03-03
3223441199635557K950055A4722 OLYMPUS OPTICAL OBTURATORHIH1995-02-21
234831037689557K944912OLYMPUS NBD TUBESFGE1995-06-13
370241528437725K944912OLYMPUS NBD TUBESFGE1995-06-13
234831781612773K944610OLYMPUS ULTRASONIC PROBESITX1995-04-10
234831971037287K944201HI-Q HAND INSTRUMENTS- UROLOGYGCJ1994-11-29
3223441971037287K944201HI-Q HAND INSTRUMENTS- UROLOGYGCJ1994-11-29
3223441420505752K944200HI-Q HAND INSTRUMENTS, OB/GYN USEHET1995-09-15
3223441443526622K944072OLYMPUS NASAL AND SINUS ENDOSCOPESEOB1995-01-11
234831581794736K942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESFDT1994-11-30
370241209495714K941743CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMPHIG1995-04-19
370241232251632K940133THE EXPANDACELL EAR PACKLRD1994-05-23
3223441306126453K936304ELECTROSURGICAL PENCILGEI1994-06-13
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
234831919641959K933200OLYMPUS PBD STENTSFGE1995-04-05
3223441707483864K931995RESECTOSCOPE SHEATHFJL1993-07-23
3223441111102156K931994RESECTOSCOPE SHEATHHIH1994-02-17
3223441338841457K931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCESHIH1994-06-08
1103721734518701K931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCESHIH1994-06-08
3223441638060166K931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSFAS1994-08-29
1103721757062860K931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSFAS1994-08-29
234831922810643K931154EVIS 200 SYSTEMEOQ1993-10-07
3223441719134897K930041VICROSAFE 6 AND VICROSAFE 12FYD1993-11-03
234831927469006K926514ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20ODG1993-08-16
3223441537175841K924732PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEMFYD1993-09-13
3223441009267201K923982OLYMPUS OES LAPAROSCOPY SYSTEMGCJ1993-03-15
370241238942717K921433ATTIC DEFECT PLATEETC1993-03-18
370241146961321K914496SCLEROTHERAPY NEEDLEFBK1991-12-05
3223441772040401K912362OES THORACOSCOPE SYSTEMEWY1991-10-24
370241287573643K912120URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPEFBN1991-08-07
234831956524163K912120URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPEFBN1991-08-07
234831534616352K911904MODELS UES-10 & PSD-10GEI1991-07-26
370241872470461K911904MODELS UES-10 & PSD-10GEI1991-07-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI472026-07-01
EOQ372026-04-23
KNS282025-11-25
GCJ202022-03-09
HIH182022-09-02
EOB152026-03-20
FAS152021-08-03
FET132026-06-24
FDF132025-05-15
FDT122026-02-22
ITX122025-09-18
FGE112025-10-21
FDS112025-05-01
KGE92026-03-06
FCG92025-10-24
FBK92025-10-16
ODG82026-07-31
HIF82025-01-13
HET82021-09-17
NEZ82019-03-05
LFL72021-08-04
NWB72014-08-07
IYN62025-01-17
FEB62020-09-01
FGB62020-08-28
FBN62010-03-10
PKL52026-05-21
FAJ42026-05-21
KTI42025-07-29
LQR42025-03-18
KCT42021-09-15
FDI42017-12-07
FYD42014-03-03
ETB42000-02-11
FDX32025-12-18
OWN32025-11-12
BTG32025-06-12
ODD32025-05-27
HIN32014-11-21
HIG32013-04-04

NDC#

PMN#

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next