FDA applicant
Genesis Medical, Inc.
FDA records 2 decisions for Genesis Medical, Inc. (Sunnyvale, CA) from 2000 to 2005: 2 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KWS (Prosthesis, Shoulder, Semi-Constrained…). No recall is linked to its devices.
FDA’s records also spell it “Genesis Medical LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Genesis Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Genesis Medical, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Genesis Medical, 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 “Genesis”
FDA records each applicant name separately; these may or may not be the same firm.