FDA.reportPublic FDA data

OLYMPUS WINTER & IBE GMBH

Matched from indexed company URL: Olympus Winter & Ibe GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96107733002807798OLYMPUS WINTER & IBE GMBH1N2027-01-01KUEHNSTRASSE 61 HAMBURG DE 22045
30037243343003724334Olympus Winter & Ibe GmbH1N2027-01-01Berlin facility Rheinstrasse 8 TELTOW Brandenburg DE 14513

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
04042761081757Olympus - WA97013A+1(800)401-1086xx@xx.xx
04042761082297Olympus - Light-guide cable, 2.8 mm, 3 m, CF type+1(800)401-1086xx@xx.xx
04042761082303Olympus - Light-guide cable, 4.25 mm, 3 m, CF type+1(800)401-1086xx@xx.xx
04042761083102Olympus - WT218700+1(800)401-1086xx@xx.xx
04042761083119Olympus - WT218705+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
3223441988984750K992901GYNECARE VERSAPOINT G-VAP ELECTRODEHIH2000-01-18
3223441971835596K992141OLYMPUS WORKING ELEMENT FOR PROBESFDC1999-09-29
3223441529946676K990237TROCAR SYSTEM ACCORDING TO HASSONGCJ1999-07-12
3223441562382610K984417BIPOLAR GRASPING FORCEPS BIQ+GEI1999-02-24
3223441874874457K983811UNIPOLAR OPTICAL BIOPSY FORCEPSKGE1998-12-24
3223441144881466K982738VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH1999-03-01
3223441467102918K962482SCUBA SYSTEMHIH1996-11-01
3223441573576785K955623OLYMPUS BIPOLAR FORCEPSGEI1996-02-13
3222761393234308K955456OES LAPARO-THORACO VIDEOSCOPE (RIGID)HET1996-02-22
3223441558986347K954488ROLLER ELECTRODEHIH1997-03-06
3223442023097842K951863ROLLER ELECTRODEFAS1995-08-24
3223441125800326K951855ULTRATHIN URETEROSCOPESFGB1995-08-16
3223441245740833K951354OLYMPUS ARTHROSCOPY SYSTEMHRX1995-06-14
3223441525681210K950278MINI LAPAROSCOPY FOR GENERAL SURGERYGCJ1995-02-01
3223441657959478K950076LAPAROSCOPEGCJ1995-03-03
3223441199635557K950055A4722 OLYMPUS OPTICAL OBTURATORHIH1995-02-21
3223441971037287K944201HI-Q HAND INSTRUMENTS- UROLOGYGCJ1994-11-29
3223441420505752K944200HI-Q HAND INSTRUMENTS, OB/GYN USEHET1995-09-15
3223441443526622K944072OLYMPUS NASAL AND SINUS ENDOSCOPESEOB1995-01-11
3223441306126453K936304ELECTROSURGICAL PENCILGEI1994-06-13
3223441707483864K931995RESECTOSCOPE SHEATHFJL1993-07-23
3223441111102156K931994RESECTOSCOPE SHEATHHIH1994-02-17
3223441338841457K931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCESHIH1994-06-08
3223441638060166K931763HF-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
3223441772040401K912362OES THORACOSCOPE SYSTEMEWY1991-10-24
3223441827909346K904940OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIESFJL1992-01-13
3223441519846883K904939FLEXIBLE AND RIGID URETEROTOME SYSTEMEZO1992-01-07
3223441697543841K903323RESECTOSCOPE LOOPSKNS1990-10-01
3223442030118316K897003OLYMPUS HYSTERORESECTOSCOPEHIH1990-03-16
3223441339395906K891451OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPEHIH1989-10-02
3223441796616989K853486OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPEFGA1985-09-12
3223441079697837K852888OLYMPUS RIGID URETERORENOSCOPEFGB1985-08-21
3223441179438487K790071ENDOSCOPE AND ACCESSORIESGCP1979-04-02
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
3223441698655512K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)GEI2025-09-23
3222761698655512K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)GEI2025-09-23
3222761541432799K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)GEI2023-08-18
3223441541432799K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)GEI2023-08-18
3223441718352884K223183Light-Guide CablesHBI2023-01-13
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
3222761344311858K203682Electrosurgical 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
3222761793250497K203277Electrosurgical 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
3222761444757744K182587Device Electrosurgical Generator ESG-150GEI2018-11-29
3223441444757744K182587Device Electrosurgical Generator ESG-150GEI2018-11-29
3222761054585225K180200ESG-300, APU-300, Pressure Reducer, MAPC ProbesGEI2018-04-26
3223441054585225K180200ESG-300, APU-300, Pressure Reducer, MAPC ProbesGEI2018-04-26
3223441515930370K173877BOWA Neutral ElectrodesGEI2018-02-15
3223441178109135K171965Resection Electrodes with HF cableFAS2017-09-28
3223441078891980K171692Instrument basket, for EndoEYEKCT2018-04-02
3223441941368085K161600Resection ElectrodesJOS2016-09-06
3222761281224653K160639Electrosurgical Generator ESG-200GEI2016-05-04
3223441281224653K160639Electrosurgical Generator ESG-200GEI2016-05-04
3223441950883730K160249ULTRA TelescopesHRX2016-04-21
3223441417266869K160053Monopolar single-use HF cableGEI2016-05-06
3223441136710703K153009ULTRA TelescopesEOB2016-04-05
3223441599742356K152092Resection ElectrodesFAS2015-10-26
3223442047809943K151191OES ELITE Telescopes, Protective TubeFBP2015-11-24
3223441306385916K150633ULTRA TelescopesGCJ2015-04-29
3223441515310601K150024Bissinger Monopolar CablesGEI2015-02-20
3223441900764909K143474Artemis Hand Held Imaging SystemOWN2015-06-30
3223441632171139K142525PK Lap LoopHIN2014-11-21
3223441831273386K142249SCHOELLY SINUSCOPEEOB2015-01-27
3223441251714861K140624HICURA HAND INSTRUMENTSGEI2014-12-10
3223441477756872K133311ENDOLEDNTN2014-07-30
3223441418676496K131402VISICLEAR SMOKE EVACUATION SYSTEMFYD2014-03-03
3223441595176303K123732HYSTEROSCOPY PUMP HM6HIG2013-04-04
3223441092487842K122167NEXXIS ORDXJ2013-04-22
3223441512611573K120418ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIESFAS2012-06-20
3223441122826337K111751VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSHIN2011-12-02
3222761122826337K111751VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSHIN2011-12-02
3223441287041279K111342LIGHT GUIDE CABLEHBI2011-11-25
3223441496476020K111202SURGICAL TISSUE MANAGEMENT SYSTEMGEI2012-01-20
3222761496476020K111202SURGICAL TISSUE MANAGEMENT SYSTEMGEI2012-01-20
3223441860141377K110748OLYMPUS INSTRUMENT TRAYKCT2012-02-15
3223441583996503K103375PLUMEPEN INTEGRATED SMOKE EVACUATION PENCILGEI2011-03-16
3223441287207010K100275WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDSFAS2010-07-01
3223441473547237K090980HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015LNWB2009-06-29
3222761143726426K073207OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167GEI2008-05-08
3223441143726426K073207OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167GEI2008-05-08
3223441979265614K070812DISPOSABLE LAPAROSCOPIC INSTRUMENTGEI2007-09-14
3223441159968560K040302VERSAPOINT RESECTOSCOPIC SYSTEMHIH2004-03-09
3223441846425594K033222OLYMPUS STERILIZATION TRAYSKCT2004-08-02
3222761797463257K032838CELON ENT SYSTEMGEI2003-09-26
3223441797463257K032838CELON ENT SYSTEMGEI2003-09-26
3223441404097077K030194XUES-41 ENDOSCOPIC ELECTROSURGICAL UNITKNS2003-03-24
3223441980948139K022449HYSTEREOSCOPY PUMP HM4HIG2003-04-10
3223441793849393K000904PENADAPT 10FYD2000-06-08
3223441484836743DEN190020iTind SystemQKA2020-02-25
3223441039080198DEN150028PneumoLinerPMU2016-04-07
3223441009080247
3223441011811875
3223441063718910
3223441074565239
3223441088463144
3223441091514246
3223441099214744
3223441117928064
3223441121717328
3223441135956332
3223441150055460
3223441153725885
3223441203193204
3223441209466865
3223441262658093

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI302025-09-23
HIH122021-12-22
FAS72021-08-03
GCJ72020-04-03
KCT42021-09-15
FYD42014-03-03
FGB32020-08-28
HET32019-08-29
EOB32016-04-05
HIN32014-11-21
HBI22023-01-13
QKA22021-06-25
OWN22020-07-17
PMU22020-02-25
HRX22016-04-21
HIG22013-04-04
KNS22003-03-24
FJL21993-07-23
FAJ12026-05-21
FED12021-07-30
JOS12016-09-06
FBP12015-11-24
NTN12014-07-30
DXJ12013-04-22
NWB12009-06-29
FDC11999-09-29
KGE11998-12-24
EZO11992-01-07
EWY11991-10-24
FGA11985-09-12
GCP11979-04-02

PMN#

GUDID#

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