FDA applicant
Remi Sciences, Inc.
FDA records 1 decision for Remi Sciences, Inc. (Lititz, PA) in 2008: 1 510(k) clearance. All are in product code KXE (Prosthesis, Wrist, Hemi-, Ulnar). 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 Remi Sciences, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2008high 1 (2008) · low 0 (2009)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Remi Sciences, 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 “Remi”
FDA records each applicant name separately; these may or may not be the same firm.