510(k) Report

FDA applicant

Bauer Medical, Inc.

Clearwater, FL3 decisions1994–19960 recalls

FDA records 3 decisions for Bauer Medical, Inc. (Clearwater, FL) from 1994 to 1996: 3 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and GDF (Guide, Needle, Surgical). 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 Bauer Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bauer Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bauer Medical, Inc. 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?

  • KNWInstrument, Biopsy2decisions
  • GDFGuide, Needle, Surgical1decision

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K960064Temno Achieve Biopsy NeedleBauer Medical, Inc. · 19965cite it

What has FDA decided for it lately?

  • K960065Temno Double Shot Biopsy NeedleBauer Medical, Inc. · 1996
  • K960064Temno Achieve Biopsy NeedleBauer Medical, Inc. · 1996
  • K935538Bauer Temno Coaxial NeedleBauer Medical, Inc. · 1994

All 3 as Bauer Medical, Inc. →

Other applicant names beginning “Bauer”

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

Bauer, Cheng & Associates, Inc. 11