FDA applicant
B. Braun of America, Inc.
FDA records 19 decisions for B. Braun of America, Inc. (Bethlehem, PA) from 1991 to 2000: 19 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and LJT (Port & Catheter, Implanted, Subcutaneous…). Its devices cite 4 predicates, 1 of them its own earlier devices. 47 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided B. Braun of America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for B. Braun of America, Inc. since 2007.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like B. Braun of America, 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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