FDA applicant

Synergy Biomedical

Collegeville, PA5 decisions2013–20240 recalls

FDA records 5 decisions for Synergy Biomedical (Collegeville, PA) from 2013 to 2024: 5 510(k) clearances. All are in product code MQV (Filler, Bone Void, Calcium Compound). Since 2016 its 510(k)s took a median of 238 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Synergy Biomedical, LLC”, “Synergy Biomedical, Inc.”.

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 Synergy Biomedical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2013high 2 (2018) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Synergy Biomedical by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Synergy Biomedical’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 “Synergy”

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

Synergy Spine Solutions, Inc. 2 Synergy Orthopaedics Intl., Inc. 2 Synergy Surgical Technologies, LLC 1

Synergy Biomedical

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Synergy”