FDA 510(k) Applications Submitted by Medline Industries, LP
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K234132 |
12/28/2023 |
Medline Reusable Sterilization Wrappers |
Medline Industries, LP |
| K233151 |
09/27/2023 |
PluroGel« Antimicrobial Burn and Wound Dressing, PluroGel« Burn and Wound Dressing (OTC) |
Medline Industries, LP |
| K220365 |
02/08/2022 |
Gemini Sterilization Wrap |
Medline Industries, LP |
| K220511 |
02/22/2022 |
Medline UNITE IM Fibula Implant |
Medline Industries, LP |
| K221360 |
05/11/2022 |
Medline UNITE« Medial Malleolus Peg Plate System |
Medline Industries, LP |
| K241359 |
05/14/2024 |
Medline UNITE« MIS Foot Recon Screw System |
Medline Industries, LP |
| K231885 |
06/27/2023 |
Medline UNITE« REFLEX« Nitinol Staple System |
Medline Industries, LP |
| K232905 |
09/19/2023 |
Medline UNITE« REFLEX« Nitinol Staple Kit |
Medline Industries, LP |
| K213567 |
11/09/2021 |
Medline UNITE Calcaneal Fracture Plating System |
Medline Industries, LP |
| K243888 |
12/18/2024 |
Medline UNITE« REFLEX« Hybrid Nitinol Implant System |
Medline Industries, LP |
| K242370 |
08/09/2024 |
Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) |
Medline Industries, LP |
| K230235 |
01/27/2023 |
Medline Luer Lock Syringes |
Medline Industries, LP |
| K231907 |
06/29/2023 |
Medline Safety Insulin and TB Syringes |
Medline Industries, LP |
| K223236 |
10/19/2022 |
Medline Surgical Face Mask and Medline Procedural Face Mask |
Medline Industries, LP |
| K233526 |
11/01/2023 |
Medline Open-back Level 3 Protective Gown |
Medline Industries, LP |
| K231058 |
04/13/2023 |
Hudson RCI« AddiPak« Unit Dose Vial |
Medline Industries, LP |
| K234032 |
12/20/2023 |
Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/D |
Medline Industries, LP |
|
|
