FDA applicant

Orion Life Systems, Inc.

Wheeling, IL33 decisions1990–19951 recall

FDA records 33 decisions for Orion Life Systems, Inc. (Wheeling, IL) from 1990 to 1995: 33 510(k) clearances. Most are in product codes JOL (Catheter And Tip, Suction) and FCM (Tray, Catheterization, Sterile Urethral, With…). 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Orion Life Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orion Life Systems, Inc. since 2007.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Orion Life 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 “Orion”

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

Orion Diagnostica, Inc. 32 Orion Corp. 21 Orion Diagnostica, Div. Orion Corp. 4 Orion Corporation Soredex 4 Orion Industries 1 Orion Biotech, Inc. 1

Orion Life Systems, 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 “Orion”