FDA applicant

Olympus Life Science Research Europa GmbH (Europa)

O'Callaghans Mills, Co. Clare, IE3 decisions2008–20090 recalls

FDA records 3 decisions for Olympus Life Science Research Europa GmbH (Europa) (O'Callaghans Mills, Co. Clare, IE) from 2008 to 2009: 3 510(k) clearances. Most are in product codes LOJ (Kit, Test,Alpha-Fetoprotein For Testicular…) and CIG (Diazo Colorimetry, Bilirubin). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Olympus Life Science Research Europa GmbH (Europa)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008high 2 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Olympus Life Science Research Europa GmbH (Europa) by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Olympus Life Science Research Europa…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Olympus”

FDA records each applicant name separately; these may or may not be the same firm.

Olympus Medical Systems Corp. 190 Olympus America, Inc. 149 Olympus Corp. 149 Olympus Optical Co., Ltd. 48 Olympus Winter & Ibe GmbH 43 Olympus Surgical Technologies America 14 Olympus Diagnostica GmbH 4 Olympus Terumo Biomaterials Corporation 3 Olympus Life & Material Science Europa GmbH (Irish 3 Olympus Corp of America 2 Olympus Opto-Electronics Co., Ltd. 2 Olympus America Inc. / Scientific Equipment Group 1

Olympus Life Science Research Europa GmbH (Europa)

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Olympus”