Case Studies - FDA 510k

Device Name: Polydioxanone Absorbable Surgical Suture
Device Code: NEW, Class II
Project Start Date: February 2024
Project End Date: June 2025

Device Name: Sterile Irrigation Solution
Device Code: FRO, Class II
Project Start Date: June 2024
Project End Date: August 2025

Device Name: Recirculating Air Cleaner
Device Code: FRF
Project Start Date: September 2022
Project End Date:  December 2024

Device Name: Nitrile Examination Gloves
Device Code: LZA
Project Start Date: September 2022
Project End Date:  December 2024

Device Name: Hypodermic Syringe
Device Code: FMF & FMI
Project Start Date: August 2023
Project End Date:  December 2024

Device Name: Pedicle Screw System
Device Code: NKB
Project Start Date: June 2022
Project End Date:  Octomber 2023

Device Name: Pulse Sensor
Device Code: DRG – DSI – MHX
Project Start Date: June 2023
Project End Date:  August 2024

Device Name: Polyglactin 910 Absorbable Suture
Device Code: GAM
Project Start Date: June 2024
Project End Date:  August 2025

Device Name: Sterile Latex Surgical Gloves
Device Code: KGO
Project Start Date: June 2022
Project End Date:  August 2023