Olympus Corp.
Medical device manufacturer in Tokyo, JP.
149510(k) clearances
0PMA approvals
0recalls
Device types
- CHJ Mercuric Thiocyanate, Colorimetry, Chloride 6
- CGX Alkaline Picrate, Colorimetry, Creatinine 6
- EOQ Bronchoscope (Flexible Or Rigid) 5
- JJE Analyzer, Chemistry (Photometric… 5
- HIH Hysteroscope (And Accessories) 4
- CIG Diazo Colorimetry, Bilirubin 4
- KNS Unit, Electrosurgical, Endoscopic (With Or… 3
- FGE Stents, Drains And Dilators For The Biliary… 3
- CDQ Urease And Glutamic Dehydrogenase, Urea… 3
- EWY Mediastinoscope, Surgical 3
- CEO Phosphomolybdate (Colorimetric), Inorganic… 3
- FJL Resectoscope 3
- FGB Ureteroscope And Accessories, Flexible/Rigid 2
- GMT Antigens, Ha, Treponema Pallidum 2
- JQB Kinetic Method, Gamma-Glutamyl Transpeptidase 2
- FET Endoscopic Video Imaging System/Component… 2
- LYK Angioscope 2
- JJF Analyzer, Chemistry, Micro, For Clinical Use 2
- GEI Electrosurgical, Cutting & Coagulation &… 2
- CGZ Electrode, Ion-Specific, Chloride 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K072643 | Crystaleye Spectrophotometer/Crystaleye Basic Set, Model CE100-DC/USKZN · Traditional | 11/16/2007SE |
| K043128 | Olympus EndoarmGWG · Traditional | 12/21/2004SE |
| K042140 | Olympus BF Type UC160-OL8ODG · Traditional | 08/18/2004SE |
| K041494 | Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery UCES-2)…FET · Special | 07/01/2004SE |
| K040940 | Bronchovideoscope Olympus XBF-D160HMEOQ · Traditional | 04/19/2004SE |
| K915402 | EW-10 and EW-20FEB · Traditional | 06/23/1995SN |
| K933200 | Olympus PBD StentsFGE · Traditional | 04/05/1995SE |
| K942338 | Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesFDT · Traditional | 11/30/1994SE |
| K931763 | Hf-Resection Electrode, Loop W/Runner Endos/AccessFAS · Traditional | 08/29/1994SE |
| K934835 | FlovalFJL · Traditional | 06/21/1994SE |
| K931764 | HF Resection Electrode, Loop W/Runner Hyster/AccesHIH · Traditional | 06/08/1994SE |
| K915857 | Flexible Tip Thoracoscope/LaparoscopeHET · Traditional | 03/11/1994SE |
| K931994 | Resectoscope SheathHIH · Traditional | 02/17/1994SE |
| K934889 | Olympus Imagemanager SystemLMB · Traditional | 01/28/1994SE |
| K934888 | Olympus ImagemanagersystemLMB · Traditional | 01/25/1994SE |
| K933992 | Olympus Sclerotherapy BalloonKNQ · Traditional | 12/21/1993SE |
| K934361 | Olympus Creatinine ReagentCGX · Traditional | 11/16/1993SE |
| K934136 | Olympus Chloride Reagent, ModificationCHJ · Traditional | 11/05/1993SE |
| K933110 | Olympus Guide WireOCY · Traditional | 11/04/1993SE |
| K933717 | Olympus Measuring DevicesFDS · Traditional | 11/02/1993SE |
| K931301 | Olympus Amylase ReagentCIJ · Traditional | 10/18/1993SE |
| K931154 | Evis 200 SystemEOQ · Traditional | 10/07/1993SE |
| K931939 | Olympus Creatinine ReagentCGX · Traditional | 09/21/1993SE |
| K932528 | Olympus Chlorid Reagent, ModifiedCHJ · Traditional | 09/17/1993SE |
| K931835 | Olympus Reply Inorganic Phosphorous ReagentCEO · Traditional | 09/08/1993SE |
| K931744 | Olympus Reply Glucose ReagentJJE · Traditional | 08/31/1993SE |
| K931745 | Olympus Reply Urea Nitrogen ReagentCDQ · Traditional | 08/19/1993SE |
| K926514 | Endoscopic Ultrasound System Type 20ODG · Traditional | 08/16/1993SE |
| K931995 | Resectoscope SheathFJL · Traditional | 07/23/1993SE |
| K925935 | Olympus Reply Clinical Chemistry AnalyzerJJQ · Traditional | 04/22/1993SE |
| K930241 | Olympus Disposable Biopsy ForcepsKNW · Traditional | 04/20/1993SE |
| K930215 | Flexible Trocar TubesEWY · Traditional | 03/16/1993SE |
| K923982 | Olympus Oes Laparoscopy SystemGCJ · Traditional | 03/15/1993SE |
| K925603 | Olympus Cholesterol ReagentCHH · Traditional | 02/08/1993SE |
| K924368 | Olympus Albumin ReagentCIX · Traditional | 02/08/1993SE |
| K925339 | Olylmpus Alanine Aminotransferase ReagentCKA · Traditional | 02/05/1993SE |
| K925337 | Olympus Gamma Glutamyl Transferase ReagentJQB · Traditional | 01/26/1993SE |
| K925155 | Olympus Aspartate Aminotransferase ReagentCIT · Traditional | 01/26/1993SE |
| K925113 | Olympus Uric Acid ReagentKNK · Traditional | 01/26/1993SE |
| K924832 | Olympus Creatine Kinase ReagentCGS · Traditional | 01/04/1993SE |
| K924659 | Olyumpus Total Protein ReagentCEK · Traditional | 12/29/1992SE |
| K924691 | Olympus Iron ReagentJIY · Traditional | 12/18/1992SE |
| K925338 | Olympus Chloride ReagentCHJ · Traditional | 12/11/1992SE |
| K924964 | Olympus Total Bilirubin ReagentCIG · Traditional | 12/03/1992SE |
| K924601 | Olympus Glucose ReagentCFR · Traditional | 12/03/1992SE |
| K924963 | Olympus Direct Bilirubin ReagentCIG · Traditional | 11/30/1992SE |
| K924693 | Olympus Bun ReagentCDQ · Traditional | 11/25/1992SE |
| K925057 | Olympus Inorganic Phosphorus ReagentCEO · Traditional | 11/19/1992SE |
| K925156 | Olympus Alkaline Phosphatase ReagentCJE · Traditional | 11/18/1992SE |
| K922231 | Olympus Cholesterol ReagentCHH · Traditional | 11/18/1992SE |
| K924965 | Olympus Lactate Dehydrogenase ReagentCFJ · Traditional | 11/16/1992SE |
| K924694 | Lipase Hydrolysis/Glycerot Kinase Enzyme, TriglycCDT · Traditional | 10/28/1992SE |
| K924692 | Olympus Creatinine ReagentCGX · Traditional | 10/19/1992SE |
| K924658 | Olympus Magnesium ReagentJGJ · Traditional | 10/19/1992SE |
| K924435 | Olympus Calcium ReagentCIC · Traditional | 10/19/1992SE |
| K924339 | Olympus Amylase ReagentCIW · Traditional | 10/19/1992SE |
| K923610 | Olympus Chloride ReagentCHJ · Traditional | 10/02/1992SE |
| K923609 | Olympus Total Bilirubin ReagentCIG · Traditional | 10/02/1992SE |
| K923346 | Olympus Amylase ReagentJFJ · Traditional | 10/02/1992SE |
| K923565 | Olympus Iron ReagentJIY · Traditional | 09/28/1992SE |
| K923527 | Olympus Alkaline Phosphatase ReagentCJE · Traditional | 09/28/1992SE |
| K923526 | Olympus Creatinine ReagentCGX · Traditional | 09/18/1992SE |
| K923412 | Olympus Lactate Dehydrogenase ReagentCFJ · Traditional | 09/18/1992SE |
| K923608 | Olympus Direct Bilirubin ReagentCIG · Traditional | 08/18/1992SE |
| K923564 | Olympus Inorganic Phosphorus ReagentCEO · Traditional | 08/18/1992SE |
| K923411 | Olympus Magnesium ReagentJGJ · Traditional | 08/18/1992SE |
| K922885 | Olympus Aspartate Aminotransferase ReagentCIT · Traditional | 07/28/1992SE |
| K922884 | Olympus Alanine Aminotransferase ReagentCKA · Traditional | 07/28/1992SE |
| K921718 | Olympus Ise ModuleJGS · Traditional | 07/21/1992SE |
| K922756 | Olympus Uric Acid ReagentKNK · Traditional | 07/17/1992SE |
| K922369 | Olympus Albumin ReagentCIX · Traditional | 07/17/1992SE |
| K922361 | Olympus Total Protein ReagentCEK · Traditional | 07/16/1992SE |
| K922232 | Olympus Glucose ReagentCFR · Traditional | 07/16/1992SE |
| K922459 | Olympus Creatine Kinase ReagentCGS · Traditional | 07/13/1992SE |
| K922597 | Olympus Urea Nitrogen (Bun) ReagentCDQ · Traditional | 07/10/1992SE |
| K922233 | Olympus Calcium ReagentCIC · Traditional | 07/10/1992SE |
| K922229 | Olympus Triglyceride ReagentCDT · Traditional | 07/02/1992SE |
| K922230 | Olympus GGT ReagentJQB · Traditional | 06/25/1992SE |
| K922220 | Olympus AU5200 Clinical Chemistry AnalyzerJJE · Traditional | 06/25/1992SE |
| K920942 | Olympus AU800 Clinical Chemistry AnalyzerJJG · Traditional | 06/10/1992SE |
| K920025 | Olympus Disposable Suction ValveEOQ · Traditional | 03/24/1992SE |
| K904940 | Olympus Infant Resectoscope and AccessoriesFJL · Traditional | 01/13/1992SE |
| K904939 | Flexible and Rigid Ureterotome SystemEZO · Traditional | 01/07/1992SE |
| K911702 | Olympus Retractable ValvulotomeMGZ · Traditional | 12/27/1991SE |
| K913829 | Olympus Flexible Tip ThoracoscopeEWY · Traditional | 11/22/1991SE |
| K904798 | Suprapubic Flow ControllerKOB · Traditional | 11/22/1991SE |
| K912362 | Oes Thoracoscope SystemEWY · Traditional | 10/24/1991SE |
| K912120 | URF-P2 Ureterorenofiberscope/CholedochofiberscopeFBN · Traditional | 08/07/1991SE |
| K911904 | Models UES-10 & PSD-10GEI · Traditional | 07/26/1991SE |
| K911640 | Olympus PK Tp(Tm) System, ModificationGMT · Traditional | 07/24/1991SE |
| K911278 | Olympus Af Angioscope SystemLYK · Traditional | 07/17/1991SE |
| K911412 | Olympus Disposable Biopsy ValveEOQ · Traditional | 06/28/1991SE |
| K910933 | Olympus Angioscopy Irrigation SheathDYB · Traditional | 06/03/1991SE |
| K911266 | Modified PK TP ControlGMT · Traditional | 05/07/1991SE |
| K910423 | Bronchoscope BF-N20EOQ · Traditional | 04/29/1991SE |
| K900880 | Olympus JF-UM3-7.5/-12 and CF-UM3-7.5/-12ITX · Traditional | 04/29/1991SE |
| K904800 | Sif-SwFDA · Traditional | 03/27/1991SE |
| K904799 | CHF-B20 CholedochoscopeFBN · Traditional | 03/27/1991SE |
| K904668 | Ie Magnetic ExtractorFCC · Traditional | 03/21/1991SE |
| K904669 | Balloon CathetersFGE · Traditional | 03/15/1991SE |
| K910147 | Creatinine Reagent(Creat), Cat.# RE0015/MODIFIEDCGX · Traditional | 03/11/1991SE |
| K910133 | Chloride Reagent (C1), Catalog No. DR0011/MODIFIEDCHJ · Traditional | 02/27/1991SE |
| K903842 | ST-E1 OvertubeFED · Traditional | 01/23/1991SE |
| K903529 | BML SeriesLQC · Traditional | 01/23/1991SE |
| K904667 | Na NeedlesGDM · Traditional | 12/12/1990SE |
| K903323 | Resectoscope LoopsKNS · Traditional | 10/01/1990SE |
| K902737 | BC BrushesFDX · Traditional | 08/24/1990SE |
| K902736 | NM Injection NeedlesFBK · Traditional | 08/24/1990SE |
| K902734 | PR CannulasFGE · Traditional | 08/22/1990SE |
| K902735 | SD SnaresGEI · Traditional | 08/02/1990SE |
| K901500 | Chloride Reagent for the AU5000 Clinical Lab. Ana.CHJ · Traditional | 07/10/1990SE |
| K901298 | Creatinine Reagent for AU5000 Clin Lab Anal-ModifyCGX · Traditional | 04/25/1990SE |
| K897003 | Olympus HysteroresectoscopeHIH · Traditional | 03/16/1990SE |
| K895878 | Olympus Valvulotome W/Detachable TipDWX · Traditional | 01/02/1990SE |
| K894496 | Olympus Valvulotome W/Fixed TipDWX · Traditional | 10/12/1989SE |
| K891451 | Olympus Hyf-P Flexible HysterofiberscopeHIH · Traditional | 10/02/1989SE |
| K893768 | Modified PK300 Automatic Eia AnalyzerJJF · Traditional | 08/15/1989SE |
| K893628 | Olympus Ise Module for AU5000CGZ · Traditional | 08/11/1989SE |
| K885193 | Olympus Ise ModuleCGZ · Traditional | 02/03/1989SE |
| K884310 | Angiopump Tubing SetDWF · Traditional | 01/10/1989SE |
| K882061 | Olympus GF-UM3/EU-M3GDB · Traditional | 11/15/1988SE |
| K882451 | Olympus Reply Chemistry AnalyzerJJE · Traditional | 09/08/1988SE |
| K873100 | Olympus Angioscopy SheathDYB · Traditional | 02/29/1988SE |
| K873367 | Olympus Lus Ultrasonic LithotripterFEO · Traditional | 11/30/1987SE |
| K871517 | Olympus PF-25 Ultrathin AngioscopeDQX · Traditional | 11/30/1987SE |
| K872027 | Olympus GF-UM2/EU-M2IYO · Traditional | 08/17/1987SE |
| K871422 | Olympus Angioscopy PumpDQI · Traditional | 08/12/1987SE |
| K864834 | Olympus PK300JJF · Traditional | 02/20/1987SE |
| K860858 | Olympus PF-18 & PF-25 Ultrathin AngioscopeLYK · Traditional | 11/20/1986SE |
| K862148 | Olympus Au 5000 Flame Photometer ModuleJJO · Traditional | 09/29/1986SE |
| K860080 | Olympus Au 5000 Chemistry Analyzer SystemJJE · Traditional | 01/24/1986SE |
| K853585 | Olympus Evs-Endoscopic Video Image & Data SysFET · Traditional | 01/21/1986SE |
| K852980 | OCS-2 ColposcopeHEX · Traditional | 10/23/1985SE |
| K853486 | Olympus Rigid Percutaneous NephroscopeFGA · Traditional | 09/12/1985SE |
| K852888 | Olympus Rigid UreterorenoscopeFGB · Traditional | 08/21/1985SE |
| K850978 | Olympus LF-1 Intubation ScopeCAL · Traditional | 05/23/1985SE |
| K851096 | Hpu Heat Probe Automated Electrocautery SystemKNS · Traditional | 05/22/1985SE |
| K843899 | Grc-Wt, Grc-WHKI · Traditional | 01/28/1985SE |
| K844143 | Olympus PF-27M Flexible UreterorenoscopeFGB · Traditional | 01/15/1985SE |
| K843084 | Olympus CHP-P10 Nephroscope/CystoscopeFBO · Traditional | 01/03/1985SE |
| K831055 | Hemoglobin Electrophoresis Meth on The-JBO · Traditional | 06/08/1983SE |
| K830762 | Olympus High Speed AnalyzerJJE · Traditional | 04/12/1983SE |
| K810503 | Flexible Choledochoscope/NephroscopeNWS · Traditional | 04/03/1981SE |
| K802187 | Sterile Disposable Cytology Brush · Traditional | 09/10/1980SESP |
| K801452 | Orotracheal Intubation EndoscopeCCW · Traditional | 07/14/1980SE |
| K790071 | Endoscope and AccessoriesGCP · Traditional | 04/02/1979SE |
| K780972 | Quickrate Reaction Rate AnalyzerJJI · Traditional | 08/14/1978SE |
| K780774 | Papillotomy KnivesKNS · Traditional | 07/27/1978SE |
| K780901 | Automated Electrophoresis SystemJQT · Traditional | 06/28/1978SE |