510(k) Report

FDA applicant

Adam Spence Corp.

Wall, NJ3 decisions1995–19990 recalls

FDA records 3 decisions for Adam Spence Corp. (Wall, NJ) from 1995 to 1999: 3 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and DYB (Introducer, Catheter). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, cardiovascular panel, where it files most

How often FDA has decided Adam Spence Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Adam Spence Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Adam Spence 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 “Adam”

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