FDA 510(k) Applications Submitted by Emily DiMambro

FDA 510(k) Number Submission Date Device Name Applicant
K220459 02/17/2022 Mako Total Knee Application Mako Surgical Corp.
K180612 03/08/2018 Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts Howmedica Osteonics Corp aka Stryker Orthopaedics
K220930 03/31/2022 Restoris Multi-Compartmental Knee System Mako Surgical Corp.
K231918 06/29/2023 Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter Koru Medical Systems


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact