510(k) Report

FDA applicant

Associated Medical Devices, Inc.

Carlsbad, CA2 decisions1982–19860 recalls

FDA records 2 decisions for Associated Medical Devices, Inc. (Carlsbad, CA) from 1982 to 1986: 2 510(k) clearances. Most are in product codes DRO (Pacemaker, Cardiac, External Transcutaneous…) and DXQ (Blood Pressure Cuff). 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 Associated Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Associated Medical Devices, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Associated Medical Devices, 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?

  • DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)1decision
  • DXQBlood Pressure Cuff1decision

What has FDA decided for it lately?

  • K854853NI-Pacer 1Associated Medical Devices, Inc. · 1986
  • K821095SphyguriteAssociated Medical Devices, Inc. · 1982

All 2 as Associated Medical Devices, Inc. →

Other applicant names beginning “Associated”

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

Associated Medical Products Co. 29Associated Mills, Inc. 14Associated Ent., Inc. 4Associated Medical 3Associated Electro-Medical Services, Inc. 2Associated Hospital Services, Inc. 1Associated Electrolysis Group 1Associated Premium Corp. 1Associated Medical Representatives 1Associated Hearing Instruments 1