FDA Device Intelligence
HomeOLYMPUS Winter & Ibe GmbH › Olympus

Olympus

OLYMPUS Winter & Ibe GmbH · Model WA96100A · UDI-DI 04042761069663

EQL Prescription
8
510(k) clearances
149
Adverse events
2
Recalls
35
Facilities

Recalls

DateFirmReason
2016-12-12Pentax of America IncPentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
2016-04-06Pentax Medical CompanyPentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.