FDA applicant
Orbusneich Medical Trading, Inc.
FDA records 7 decisions for Orbusneich Medical Trading, Inc. (Fort Lauderdale, FL) from 2018 to 2020: 7 510(k) clearances. Most are in product codes LOX (Catheters, Transluminal Coronary Angioplasty…) and PNO (Catheter, Percutaneous, Cutting/Scoring). Since 2016 its 510(k)s took a median of 76 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 1 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 Orbusneich Medical Trading, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Orbusneich Medical Trading, 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) ReportOther applicant names beginning “Orbusneich”
FDA records each applicant name separately; these may or may not be the same firm.