FDA applicant
Ultraguide, Ltd.
FDA records 6 decisions for Ultraguide, Ltd. (Hasbrouck Heights, NJ) from 1998 to 2002: 6 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and JAK (System, X-Ray, Tomography, Computed). Its devices cite 7 predicates, 4 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 Ultraguide, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ultraguide, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ultraguide, Ltd.’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