FDA applicant

Impact Case Technologies, Inc.

Markham, Ontario, CA1 decision1997–19970 recalls

FDA records 1 decision for Impact Case Technologies, Inc. (Markham, Ontario, CA) in 1997: 1 510(k) clearance. All are in product code MLW (Warmer, Peritoneal Dialysate). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Impact Case Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Impact Case Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Impact Case Technologies, 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 “Impact”

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

Impact Instrumentation, Inc. 27 Impact Applications, Inc. 6 Impact Medical, LLC 1 Impact Systems Corp. 1 Impact Packaging Corp. 1 Impact Wheelchair Manufacture, Inc. 1 Impact Monitors, Inc. 1

Impact Case Technologies, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Impact”