FDA applicant

Ortho Pharmaceutical Corp.

Raritan, NJ9 decisions1979–19960 recalls

FDA records 9 decisions for Ortho Pharmaceutical Corp. (Raritan, NJ) from 1979 to 1996: 9 510(k) clearances. Most are in product codes HIS (Condom) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 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 Ortho Pharmaceutical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ortho Pharmaceutical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Ortho”

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

Ortho-Clinical Diagnostics, Inc. 152 Ortho Diagnostic Systems, Inc. 126 Ortho Development Corp. 64 Ortho Diagnostics, Inc. 24 Ortho Tec, LLC 22 Ortho Source 9 Ortho Organizers, Inc. 8 Ortho Kinetics Corp. 7 Ortho Solutions Limited 6 Ortho Instruments 6 Ortho Kinematics, Inc. 6 Ortho Solutions UK, Ltd. 5

Ortho Pharmaceutical Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ortho”