Company ยท US
Olympus Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2007. Name variants (Inc, Corp, punctuation) are merged.
149510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 6 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 6 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 5 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 5 |
| CIG | Diazo Colorimetry, Bilirubin | 4 |
| HIH | Hysteroscope (And Accessories) | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 3 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 3 |
| EWY | Mediastinoscope, Surgical | 3 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 |
| FJL | Resectoscope | 3 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 |
| CFR | Hexokinase, Glucose | 2 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 |
| CGZ | Electrode, Ion-Specific, Chloride | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| CIC | Cresolphthalein Complexone, Calcium | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2007 | K072643 | CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US Olympus Corporation, JP | KZN |
| Dec 21, 2004 | K043128 | OLYMPUS ENDOARM Olympus Corporation | GWG |
| Aug 18, 2004 | K042140 | OLYMPUS BF TYPE UC160-OL8 Olympus Corporation | ODG |
| Jul 1, 2004 | K041494 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 Olympus Corporation | FET |
| Apr 19, 2004 | K040940 | BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM Olympus Corporation | EOQ |
| Jun 23, 1995 | K915402 | EW-10 AND EW-20 Olympus Corp. | FEB |
| Apr 5, 1995 | K933200 | OLYMPUS PBD STENTS Olympus Corp. | FGE |
| Nov 30, 1994 | K942338 | OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES Olympus Corp. | FDT |
| Aug 29, 1994 | K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS Olympus Corp. | FAS |
| Jun 21, 1994 | K934835 | FLOVAL Olympus Corp. | FJL |
| Jun 8, 1994 | K931764 | HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES Olympus Corp. | HIH |
| Mar 11, 1994 | K915857 | FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE Olympus Corp. | HET |
| Feb 17, 1994 | K931994 | RESECTOSCOPE SHEATH Olympus Corp. | HIH |
| Jan 28, 1994 | K934889 | OLYMPUS IMAGEMANAGER SYSTEM Olympus | LMB |
| Jan 25, 1994 | K934888 | OLYMPUS IMAGEMANAGERSYSTEM Olympus | LMB |
| Dec 21, 1993 | K933992 | OLYMPUS SCLEROTHERAPY BALLOON Olympus Corp. | KNQ |
| Nov 16, 1993 | K934361 | OLYMPUS CREATININE REAGENT Olympus Corp. | CGX |
| Nov 5, 1993 | K934136 | OLYMPUS CHLORIDE REAGENT, MODIFICATION Olympus Corp. | CHJ |
| Nov 4, 1993 | K933110 | OLYMPUS GUIDE WIRE Olympus Corp. | OCY |
| Nov 2, 1993 | K933717 | OLYMPUS MEASURING DEVICES Olympus Corp. | FDS |
| Oct 18, 1993 | K931301 | OLYMPUS AMYLASE REAGENT Olympus Corp. | CIJ |
| Oct 7, 1993 | K931154 | EVIS 200 SYSTEM Olympus Corp. | EOQ |
| Sep 21, 1993 | K931939 | OLYMPUS CREATININE REAGENT Olympus Corp. | CGX |
| Sep 17, 1993 | K932528 | OLYMPUS CHLORID REAGENT, MODIFIED Olympus Corp. | CHJ |
| Sep 8, 1993 | K931835 | OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT Olympus Corp. | CEO |
| Aug 31, 1993 | K931744 | OLYMPUS REPLY GLUCOSE REAGENT Olympus Corp. | JJE |
| Aug 19, 1993 | K931745 | OLYMPUS REPLY UREA NITROGEN REAGENT Olympus Corp. | CDQ |
| Aug 16, 1993 | K926514 | ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20 Olympus Corp. | ODG |
| Jul 23, 1993 | K931995 | RESECTOSCOPE SHEATH Olympus Corp. | FJL |
| Apr 22, 1993 | K925935 | OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER Olympus Corp. | JJQ |
| Apr 20, 1993 | K930241 | OLYMPUS DISPOSABLE BIOPSY FORCEPS Olympus Corp. | KNW |
| Mar 16, 1993 | K930215 | FLEXIBLE TROCAR TUBES Olympus Corp. | EWY |
| Mar 15, 1993 | K923982 | OLYMPUS OES LAPAROSCOPY SYSTEM Olympus Corp. | GCJ |
| Feb 8, 1993 | K925603 | OLYMPUS CHOLESTEROL REAGENT Olympus Corp. | CHH |
| Feb 8, 1993 | K924368 | OLYMPUS ALBUMIN REAGENT Olympus Corp. | CIX |
| Feb 5, 1993 | K925339 | OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT Olympus Corp. | CKA |
| Jan 26, 1993 | K925337 | OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT Olympus Corp. | JQB |
| Jan 26, 1993 | K925155 | OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT Olympus Corp. | CIT |
| Jan 26, 1993 | K925113 | OLYMPUS URIC ACID REAGENT Olympus Corp. | KNK |
| Jan 4, 1993 | K924832 | OLYMPUS CREATINE KINASE REAGENT Olympus Corp. | CGS |
| Dec 29, 1992 | K924659 | OLYUMPUS TOTAL PROTEIN REAGENT Olympus Corp. | CEK |
| Dec 18, 1992 | K924691 | OLYMPUS IRON REAGENT Olympus Corp. | JIY |
| Dec 11, 1992 | K925338 | OLYMPUS CHLORIDE REAGENT Olympus Corp. | CHJ |
| Dec 3, 1992 | K924964 | OLYMPUS TOTAL BILIRUBIN REAGENT Olympus Corp. | CIG |
| Dec 3, 1992 | K924601 | OLYMPUS GLUCOSE REAGENT Olympus Corp. | CFR |
| Nov 30, 1992 | K924963 | OLYMPUS DIRECT BILIRUBIN REAGENT Olympus Corp. | CIG |
| Nov 25, 1992 | K924693 | OLYMPUS BUN REAGENT Olympus Corp. | CDQ |
| Nov 19, 1992 | K925057 | OLYMPUS INORGANIC PHOSPHORUS REAGENT Olympus Corp. | CEO |
| Nov 18, 1992 | K925156 | OLYMPUS ALKALINE PHOSPHATASE REAGENT Olympus Corp. | CJE |
| Nov 18, 1992 | K922231 | OLYMPUS CHOLESTEROL REAGENT Olympus Corp. | CHH |
Newest 50 of 149.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||