FDA applicant

Custom Medical Specialties, Inc.

Indianapolis, IN1 decision1995–19950 recalls

FDA records 1 decision for Custom Medical Specialties, Inc. (Indianapolis, IN) in 1995: 1 510(k) clearance. All are in product code JAY (Support, Breathing Tube). 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 Specialties, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Custom Medical Specialties, 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 Specialties, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Custom”