510(k) Report

FDA applicant

Phoenix Bioengineering, Inc.

Bridgeport, PA3 decisions1991–19930 recalls

FDA records 3 decisions for Phoenix Bioengineering, Inc. (Bridgeport, PA) from 1991 to 1993: 3 510(k) clearances. Most are in product codes GXR (Cover, Burr Hole) and KOB (Catheter, Suprapubic (And Accessories)). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Phoenix Bioengineering, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Phoenix Bioengineering, 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 “Phoenix”

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