FDA.report

OLYMPUS Corporation of the Americas

Matched from indexed company URL: OLYMPUS CORP.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
24293042429304OLYMPUS Corporation of the Americas1Y2026-01-013500 CORPORATE PKWY. CENTER VALLEY PA US 18034
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 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 GUDIDProductPhoneEmail
04042761005722Olympus - Telescope, 1.9 mm, 0°,210mm, autoclavable+1(800)401-1086xx@xx.xx
04042761005739Olympus - Telescope, 1.9 mm, 30°, 210mm, autoclavable+1(800)401-1086xx@xx.xx
04042761077729Olympus - Protective tube, 4 mm telescopes+1(800)401-1086xx@xx.xx
04953170467288ULTRASONIC PROBE - UM-3R-3+1(800)401-1086xx@xx.xx

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3223441957900258K994418VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH2000-01-24
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
1100741629228660K984358OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597FDS1999-09-17
3223441874874457K983811UNIPOLAR OPTICAL BIOPSY FORCEPSKGE1998-12-24
3223441144881466K982738VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH1999-03-01
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
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
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
3223441467102918K962482SCUBA SYSTEMHIH1996-11-01
1100741584646076K955650OLYMPUS SD SERIES SNARESFDI1996-03-29
3223441573576785K955623OLYMPUS BIPOLAR FORCEPSGEI1996-02-13
1100741143645266K955065OLYMPUS FB SERIES BIOPSY FORCEPSFCL1996-01-24
3223441558986347K954488ROLLER ELECTRODEHIH1997-03-06
1103721988414566K954488ROLLER ELECTRODEHIH1997-03-06
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
1103721225631718K951863ROLLER ELECTRODEFAS1995-08-24
3223442023097842K951863ROLLER ELECTRODEFAS1995-08-24
3223441125800326K951855ULTRATHIN URETEROSCOPESFGB1995-08-16
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
1100741738324697K950636OLYMPUS DISPOSABLE BIOPSY FORCEPSEOQ1995-02-27
3223441525681210K950278MINI LAPAROSCOPY FOR GENERAL SURGERYGCJ1995-02-01
1100741161645951K950166OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFEKNS1995-02-22
3223441657959478K950076LAPAROSCOPEGCJ1995-03-03
3223441199635557K950055A4722 OLYMPUS OPTICAL OBTURATORHIH1995-02-21
370241528437725K944912OLYMPUS NBD TUBESFGE1995-06-13
3223441971037287K944201HI-Q HAND INSTRUMENTS- UROLOGYGCJ1994-11-29
3223441420505752K944200HI-Q HAND INSTRUMENTS, OB/GYN USEHET1995-09-15
3223441443526622K944072OLYMPUS NASAL AND SINUS ENDOSCOPESEOB1995-01-11
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
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
3223441719134897K930041VICROSAFE 6 AND VICROSAFE 12FYD1993-11-03
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
370241872470461K911904MODELS UES-10 & PSD-10GEI1991-07-26
3223441827909346K904940OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIESFJL1992-01-13
3223441519846883K904939FLEXIBLE AND RIGID URETEROTOME SYSTEMEZO1992-01-07
1103722057428059K904939FLEXIBLE AND RIGID URETEROTOME SYSTEMEZO1992-01-07
370241990471800K904797SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)FBO1991-03-05
370241373801256K903529BML SERIESLQC1991-01-23
3223441697543841K903323RESECTOSCOPE LOOPSKNS1990-10-01
1103721767439049K903323RESECTOSCOPE LOOPSKNS1990-10-01
370241292761631K902737BC BRUSHESFDX1990-08-24
1100741093783316K902736NM INJECTION NEEDLESFBK1990-08-24
1100741996466214K902735SD SNARESGEI1990-08-02
370241159345750K902734PR CANNULASFGE1990-08-22
3223442030118316K897003OLYMPUS HYSTERORESECTOSCOPEHIH1990-03-16
370241820862922K893491MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300FST1989-06-22
370241003638438K891451OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPEHIH1989-10-02
3223441339395906K891451OLYMPUS 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
3223441796616989K853486OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPEFGA1985-09-12
370242062069830K852980OCS-2 COLPOSCOPEHEX1985-10-23
3223441079697837K852888OLYMPUS RIGID URETERORENOSCOPEFGB1985-08-21
370241009803960K850978OLYMPUS LF-1 INTUBATION SCOPECAL1985-05-23
3223441179438487K790071ENDOSCOPE AND ACCESSORIESGCP1979-04-02
370241807320735K781574PLASTI-PORE SEPTAL BUTTONFZE1978-09-27
370241419849160K780586MICROCLIP, WILLIAMSGDW1978-05-16
370241693174645K760435PISTON, PLATINUM TEFLON, OTOLOGY IMPLANTETB1976-09-27
3223441184200087K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,FAJ2026-05-21
1100741517970763K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)FBK2025-10-16
1100741181324695K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB2026-03-20
3223441698655512K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)GEI2025-09-23
1100741249927248K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)KTI2025-07-29
1100741518617781K250957Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)EOQ2025-05-30
1100741567660032K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)KNS2025-10-17
1100741130166399K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)KGE2025-10-07
3223441541432799K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)GEI2023-08-18
3223442013145283K221522HF-cables (resusable)GEI2023-01-19
3223441220853321K213207Sheath, Stopcock AccessoryHIH2021-12-22
3223441090721589K210651Resection Electrodes with HF cableFAS2021-08-03
3223441981056852K210138iTind SystemQKA2021-06-25
3223441344311858K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double ActionGEI2021-05-17
3223441209702501K203492Instrument tray, for semi-rigid ureteroscopeKCT2021-09-15
3223441793250497K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsGEI2021-04-28
3223441031791679K200770Mini PCNL-SystemFED2021-07-30
3223441025950960K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera HeadOWN2020-07-17
3223441102034770K200369OES Elite Ureteroscopes and AccessoriesFGB2020-08-28
3223441800401207K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DGCJ2020-04-03
3223441527941499K192898PneumoLinerPMU2020-02-25
3223441993721631K190744ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)HET2019-08-29
3223441444757744K182587Device Electrosurgical Generator ESG-150GEI2018-11-29

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
GEI342025-09-23
HIH152021-12-22
FAS152021-08-03
KNS132025-10-17
GCJ92020-04-03
EOB52026-03-20
FBK42025-10-16
KGE42025-10-07
EOQ42025-05-30
KCT42021-09-15
FYD42014-03-03
ETB42000-02-11
FGB32020-08-28
HIN32014-11-21
HIG32013-04-04
FGE32011-02-24
LMB31995-09-18
QKA22021-06-25
PMU22020-02-25
HET22019-08-29
FDI22017-12-07
JOS22016-09-06
HRX22016-04-21
HIF22012-11-13
FEB22011-02-23
ETN22002-10-24
FDC22002-05-09
ERL22002-03-08
FDF22000-12-04
ITX22000-05-26
FST21994-03-10
FJL21993-07-23
EZO21992-01-07
FAJ12026-05-21
KTI12025-07-29
FED12021-07-30
OWN12020-07-17
FBP12015-11-24
NEZ12015-02-08
NTN12014-07-30

NDC

PMN

200 records. Showing 1-40. Next

GUDID

111 records. Showing 1-40. Next