FDA applicant
J.H.Orsing AB
FDA records 1 decision for J.H.Orsing AB (Raa, SE) in 1994: 1 510(k) clearance. All are in product code DYN (Mouthpiece, Saliva Ejector). 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 J.H.Orsing AB’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for J.H.Orsing AB since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like J.H.Orsing AB’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