510(k) Report

FDA applicant

Advanced Diagnostic Medical Systems, Inc.

Dublin, CA4 decisions1988–19890 recalls

FDA records 4 decisions for Advanced Diagnostic Medical Systems, Inc. (Dublin, CA) from 1988 to 1989: 4 510(k) clearances. Most are in product codes FCI (Punch, Biopsy) and KNW (Instrument, Biopsy). 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 Advanced Diagnostic Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Diagnostic Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Diagnostic Medical Systems, 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?

  • FCIPunch, Biopsy1decision
  • KNWInstrument, Biopsy1decision
  • FCGBiopsy Needle1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

What has FDA decided for it lately?

  • K882746Adms Silent Needle GunAdvanced Diagnostic Medical Systems, Inc. · 1989
  • K890203Adms Biopsy NeedleAdvanced Diagnostic Medical Systems, Inc. · 1989
  • K881208Probe Sheath for Adms Ultrasound ProbeAdvanced Diagnostic Medical Systems, Inc. · 1988
  • K875119Biopsy Attach. for Adms Ultrasound ProbeAdvanced Diagnostic Medical Systems, Inc. · 1988

All 4 as Advanced Diagnostic Medical Systems, Inc. →