FDA applicant
L&Z Us, Inc.
FDA records 6 decisions for L&Z Us, Inc. (Norwood, NJ) from 2016 to 2023: 6 510(k) clearances. All are in product code LJS (Catheter, Intravascular, Therapeutic…). Since 2016 its 510(k)s took a median of 47 days from receipt to decision, against 74 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 0 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
How often FDA has decided L&Z Us, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like L&Z Us, 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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