510(k) Report

FDA applicant

Merck, Sharp & Dohme

West Point, PA4 decisions1976–19880 recalls

FDA records 4 decisions for Merck, Sharp & Dohme (West Point, PA) from 1976 to 1988: 4 510(k) clearances. Most are in product codes JTT (Susceptibility Test Powders, Antimicrobial) and GES (Blade, Scalpel). 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, microbiology panel, where it files most

How often FDA has decided Merck, Sharp & Dohme’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Merck, Sharp & Dohme since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JTTSusceptibility Test Powders, Antimicrobial3decisions
  • GESBlade, Scalpel1decision

What has FDA decided for it lately?

  • K880574Modified Imipenem Susceptibility PowderMerck, Sharp & Dohme · 1988
  • K864442Norfloxacin Susceptibility PowderMerck, Sharp & Dohme · 1986
  • K855071Imipenem Susceptibility PowderMerck, Sharp & Dohme · 1986
  • K760605Lightcast II Carbide BladeMerck, Sharp & Dohme · 1976

All 4 as Merck, Sharp & Dohme →

Other applicant names beginning “Merck”

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

Merck Millipore, Ltd. 2Merck Biomaterial GmbH 1