FDA applicant

Olympus Diagnostica GmbH

Melville, NY4 decisions1998–20000 recalls

FDA records 4 decisions for Olympus Diagnostica GmbH (Melville, NY) from 1998 to 2000: 4 510(k) clearances. Most are in product codes CJY (Azo Dye, Calcium) and JIT (Calibrator, Secondary). 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 Diagnostica GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Olympus Diagnostica GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Olympus Diagnostica GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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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 Life Science Research Europa GmbH (Europa) 3 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 Diagnostica GmbH

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Olympus”