FDA applicant

Kronner Medical

Roseburg, OR7 decisions1987–199025 recalls

FDA records 7 decisions for Kronner Medical (Roseburg, OR) from 1987 to 1990: 7 510(k) clearances. Most are in product codes KTT (Appliance, Fixation, Nail/Blade/Plate…) and LXH (Orthopedic Manual Surgical Instrument). 25 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Kronner Medical since 2007.

Recalls per year

25in 2014

2007high 25 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Kronner 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 “Kronner”

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

Kronner Prototypes, Inc. 4

Kronner Medical

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Kronner”