510(k) Report

FDA applicant

Osteogenics Biomedical, Inc.

Lubbock, TX8 decisions1999–20210 recalls

FDA records 8 decisions for Osteogenics Biomedical, Inc. (Lubbock, TX) from 1999 to 2021: 8 510(k) clearances. Most are in product codes NPK (Barrier, Synthetic, Intraoral) and NBY (Suture, Surgical, Nonabsorbable, Expanded…). Its devices cite 5 predicates, 1 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 Osteogenics Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12010: 12017: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Osteogenics Biomedical, 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 “Osteogenics”

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