FDA applicant

Pace Medical

Waltham, MA20 decisions1987–20010 recalls

FDA records 20 decisions for Pace Medical (Waltham, MA) from 1987 to 2001: 19 510(k) clearances and 1 original PMA approval. Most are in product codes DTE (Pulse-Generator, Pacemaker, External) and DSA (Cable, Transducer And Electrode, Patient…). 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 Pace Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pace Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Pace”

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

Pace Tech, Inc. 18 Pace Tech Medical Monitors, Inc. 3 Pace Surgical 3 Pace Pharmaceutical Services, Inc. 2 Pace West 1

Pace Medical

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Pace”