510(k) Report

FDA applicant

Stryker Sustainability Solutions

Tempe, AZ34 decisions2011–202615 recalls

FDA records 34 decisions for Stryker Sustainability Solutions (Tempe, AZ) from 2011 to 2026: 34 510(k) clearances. Most are in product codes NUJ (Electrosurgical, Cutting & Coagulation…) and NLQ (Single-Use Reprocessed Ultrasonic Surgical…). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 61 predicates, 7 of them its own earlier devices. 15 recalls are linked to its devices.

FDA’s records also spell it “Stryker Sustainability Solutions, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Stryker Sustainability Solutions’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2011: 22012: 22013: 22014: 22015: 12016: 12017: 32018: 22019: 22020: 32021: 12022: 52023: 32024: 32025: 12026 (partial year): 1
2011high 5 (2022) · low 1 (2015)2026

2026 so far, outlined.

Recalls per year

6in 2026

2018: 52020: 12021: 12024: 12025: 12026 (partial year): 6
2011high 6 (2026) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Stryker Sustainability Solutions by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Stryker”

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