FDA applicant

Kendall Mcgaw Laboratories, Inc.

Santa Ana, CA13 decisions1986–199139 recalls

FDA records 13 decisions for Kendall Mcgaw Laboratories, Inc. (Santa Ana, CA) from 1986 to 1991: 13 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and FPA (Set, Administration, Intravascular). 39 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Kendall Mcgaw Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kendall Mcgaw Laboratories, Inc. since 2007.

Recalls per year

1in 2021

2007high 29 (2009) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Kendall Mcgaw Laboratories, 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 “Kendall”

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

Kendall Healthcare Products Co. Div.Of Tyco Health 66 Kendall 22 Kendall Research Center 14 The Kendall Company Div. of Tyco Healthcare Group 4 Kendall-Ltp 1

Kendall Mcgaw Laboratories, 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?

What has been recalled?

Other applicant names beginning “Kendall”