Medical device manufacturer
Olympus America Inc.
Olympus America Inc. holds 149 FDA 510(k) clearances across 72 product codes. Median elapsed review time is 84 days. openFDA lists 21 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 149
- Product codes
- 72
- Median review
- 84 days
- Recall records
- 21
How does FDA spell Olympus America Inc.?
FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Olympus America Inc. | device/recall | normalised |
| Olympus America Inc. | device/enforcement | normalised |
| Olympus America, Inc | device/recall | normalised |
| Olympus America, Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Olympus America Inc. file in?
72 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 10 | 35 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 10 | 54 days | |
| HET | Laparoscope, Gynecologic (And Accessories) | 8 | 107 days | |
| ITX | Transducer, Ultrasonic, Diagnostic | 8 | 183 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 76 days | |
| JIT | Calibrator, Secondary | 4 | 22 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 47 days | |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 4 | 77 days | |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 3 | 61 days | |
| CFQ | Radioimmunoassay, Immunoglobulins (G, A, M) | 3 | 41 days | |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 3 | 75 days | |
| FCG | Biopsy Needle | 3 | 170 days | |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 3 | 186 days | |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 3 | 91 days | |
| HIH | Hysteroscope (And Accessories) | 3 | 46 days | |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 3 | 30 days | |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 | 50 days | |
| MND | Ligator, Esophageal | 3 | 264 days | |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 91 days | |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 2 | 22 days | |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 | 23 days | |
| DCN | System, Test, C-Reactive Protein | 2 | 36 days | |
| DHR | System, Test, Rheumatoid Factor | 2 | 28 days | |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 2 | 39 days | |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 88 days |
Showing the 25 they file in most, of 72.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Olympus America Inc. had a recall?
openFDA lists 21 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-2807-2015Class IITerminatedFDT
New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.
Z-0432-2014Class IITerminatedGEI
Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw.
Z-0329-2014Class IITerminatedFEQ
There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode.
Z-0828-2012TerminatedKNS
Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements
Z-0829-2012TerminatedKNS
Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements
Showing the 5 most recently initiated of 21.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Olympus America Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K111788 | ENDOEYE HD II | HET | 203 | |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | DHX | 282 | |
| K073490 | OLYMPUS IGG REAGENT | CFN | 61 | |
| K073489 | OLYMPUS IGA REAGENT | CFN | 61 | |
| K073487 | OLYMPUS IGM REAGENT | CFN | 61 | |
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | KNK | 193 | |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | CDT | 91 | |
| K061499 | OSFERION | MQV | 240 | |
| K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM | JLW | 90 | |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | CJY | 120 |
Source: openFDA device/510k · retrieved
Watch what Olympus America Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.