FDA applicant

Critical Care Systems, Inc.

Hollywood, FL1 decision1987–19870 recalls

FDA records 1 decision for Critical Care Systems, Inc. (Hollywood, FL) in 1987: 1 510(k) clearance. All are in product code DQK (Computer, Diagnostic, Programmable). 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 Critical Care Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Critical Care Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Critical Care Systems, 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 “Critical”

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

Critical Device Corp. 6 Critical Alert 1 Critical Care Micro Computing 1 Critical Specialties, Inc. 1 Critical Patient Care, Inc. 1 Critical Care Diagnostics, Inc. (Dba Critical Diag 1

Critical Care Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Critical”