510(k) Report

FDA applicant

T.A.G. Medical Products Corporation, Ltd.

Somerset, MA16 decisions2002–20266 recalls

FDA records 16 decisions for T.A.G. Medical Products Corporation, Ltd. (Somerset, MA) from 2002 to 2026: 16 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 101 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 9 of them its own earlier devices. 6 recalls are linked to its devices.

FDA’s records also spell it “Tag Medical Products”.

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 T.A.G. Medical Products Corporation, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2009: 22010: 12011: 22012: 12014: 12015: 12019: 12020: 12021: 12022: 12023: 22026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2017: 52023: 1
2007high 5 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — T.A.G. Medical Products Corporation, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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