FDA applicant

Pfizer, Inc.

Ny, NY39 decisions1969–20181 recall

FDA records 39 decisions for Pfizer, Inc. (Ny, NY) from 1969 to 2018: 30 510(k) clearances and 9 original PMA approvals. Most are in product codes JTT (Susceptibility Test Powders, Antimicrobial) and HRS (Plate, Fixation, Bone). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, microbiology panel, where it files most

How often FDA has decided Pfizer, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Pfizer”

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

Pfizer Laser Systems 32 Pfizer Medical Systems, Inc. 12 Pfizer Hospital Products Group, Inc. 8 Pfizer Pharmaceuticals 6

Pfizer, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Pfizer”