FDA applicant
Altana, Inc.
FDA records 2 decisions for Altana, Inc. (Melville, NY) from 1988 to 1994: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and DAN (Fibrinopeptide A, Antigen, Antiserum, Control). 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 Altana, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Altana, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Altana, 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) Report