FDA applicant

Exact Medical Manufacturing, Inc.

Buffalo, NY9 decisions2010–20231 recall

FDA records 9 decisions for Exact Medical Manufacturing, Inc. (Buffalo, NY) from 2010 to 2023: 9 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and FYA (Gown, Surgical). Its devices cite 9 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Exact Medical Manufacturing”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Exact Medical Manufacturing, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2010high 4 (2010) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2021

2010high 1 (2021) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Exact Medical Manufacturing, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Exact Medical Manufacturing, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Exact”

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

Exact Imaging, Inc. 4 Exact Sciences Corporation 3 Exact Supplies, Ltd. 1 Exact Science, Inc. 1

Exact Medical Manufacturing, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Exact”