FDA applicant

Komet Medical

Savannah, GA3 decisions1994–19990 recalls

FDA records 3 decisions for Komet Medical (Savannah, GA) from 1994 to 1999: 3 510(k) clearances. Most are in product codes GFF (Bur, Surgical, General & Plastic Surgery) and HBE (Drills, Burrs, Trephines & Accessories…). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Komet Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Komet Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Komet”

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

Komet Medical, Div. of Brasseler USA I, L.P. 1

Komet Medical

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?

Other applicant names beginning “Komet”