FDA applicant

Amedica Biotech, Inc.

Hayward, CA13 decisions2002–20102 recalls

FDA records 13 decisions for Amedica Biotech, Inc. (Hayward, CA) from 2002 to 2010: 13 510(k) clearances. Most are in product codes LDJ (Enzyme Immunoassay, Cannabinoids) and DKZ (Enzyme Immunoassay, Amphetamine). 2 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, clinical toxicology panel, where it files most

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

FDA decisions per year

1in 2010

2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Amedica Biotech, 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 “Amedica”

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

Amedica Corp. 17

Amedica Biotech, Inc.

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?

What has been recalled?

Other applicant names beginning “Amedica”