FDA applicant

Boston Pacific Medical, Inc.

Boston, MA11 decisions1992–19940 recalls

FDA records 11 decisions for Boston Pacific Medical, Inc. (Boston, MA) from 1992 to 1994: 11 510(k) clearances. Most are in product codes EZD (Catheter, Straight) and FCE (Enema Kit). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Boston Pacific Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Boston Pacific Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Boston”

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

Boston Scientific Corp 809 Boston Scientific Scimed, Inc. 40 Boston Medical Products, Inc. 33 Boston Scientific, Target 19 Boston Surgical Products, Inc. 17 Boston Biomedica, Inc. 12 Boston Scientific Neuromodulation 11 Boston Medical Corp. 8 Boston Aesthetics, Inc. 6 The Boston Medical Group 5 Boston Scientific/Medi-Tech 5 Boston Scientific /International Technologies 5

Boston Pacific Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Boston”