FDA applicant

Howmedica Leibinger, Inc.

Dallas, TX11 decisions1996–19970 recalls

FDA records 11 decisions for Howmedica Leibinger, Inc. (Dallas, TX) from 1996 to 1997: 11 510(k) clearances. Most are in product codes JEY (Plate, Bone) and HRS (Plate, Fixation, Bone). Its devices cite 36 predicates, 6 of them its own earlier devices. 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, dental panel, where it files most

How often FDA has decided Howmedica Leibinger, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Howmedica Leibinger, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Howmedica Leibinger, Inc.’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 “Howmedica”

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

Howmedica Corp. 412 Howmedica Osteonics Corp. 303 Howmedica Osteonics Corp., Dba Stryker Orthopaedics 34 Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics 11 Howmedica, Pfizer Medical Technology Group 1 Howmedica Osteonics Corp. Dba Stryker Orthopeadics 1

Howmedica Leibinger, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Howmedica”