FDA applicant

Custom Medical Concepts, Inc.

Chelmsford, MA1 decision1993–19930 recalls

FDA records 1 decision for Custom Medical Concepts, Inc. (Chelmsford, MA) in 1993: 1 510(k) clearance. All are in product code MIA (Needle, Spinal, Short Term). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Custom Medical Concepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Custom Medical Concepts, 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 “Custom”

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

Custom Pack Reliability 21 Custom Spine, Inc. 14 Custom Medical Products, Ltd. 14 Custom Services Intl., Inc. 9 Custom Orthopaedic Solutions, Inc. 8 Custom Ultrasonics 6 Custom Surgical Products, Inc. 4 Custom Optical Frames, Inc. 4 Custom Medical, Inc. 3 Custom Medical Devices Intl., Inc. 3 Custom Cardio Components 2 Custom Medical Plastics, Inc. 2

Custom Medical Concepts, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Custom”