Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Olympus CorporationLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Olympus America with 149 510(k) clearances and 4 device recalls. The most recent is a device recall dated Mar 26, 2015: EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been desi….
| Mar 26, 2015 | EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center,Class II · New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consist | Device recalls |
| Sep 27, 2013 | TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In linClass II · Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, b | Device recalls |
| May 20, 2013 | Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoClass II · There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked po | Device recalls |
| Jan 13, 2012 | ENDOEYE HD IIK111788 · HET | 510(k) clearances |
| Nov 10, 2009 | Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision ofClass II · Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancem | Device recalls |
| Mar 18, 2009 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK081615 · DHX | 510(k) clearances |
| Feb 11, 2008 | OLYMPUS IGA REAGENTK073489 · CFN | 510(k) clearances |
| Feb 11, 2008 | OLYMPUS IGG REAGENTK073490 · CFN | 510(k) clearances |
| Feb 11, 2008 | OLYMPUS IGM REAGENTK073487 · CFN | 510(k) clearances |
| Apr 6, 2007 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98K062862 · KNK | 510(k) clearances |
| Mar 23, 2007 | OLYMPUS TRIGLYCERIDE TEST SYSTEMK063804 · CDT | 510(k) clearances |
| Jan 26, 2007 | OSFERIONK061499 · MQV | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
