Medline Industries, LP - FDA 510(k) Cleared Devices
Recent clearances: Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel), Konig Bell Circumcision Clamp, Namic Radial Arm Band, 23 cm (DYNJRADBAND)
29
Total
29
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medline Industries, LP Orthopedic ✕
7 devices
Cleared
Apr 11, 2025
Medline UNITE® REFLEX® Hybrid Nitinol Implant System
Orthopedic
114d
Cleared
Aug 02, 2024
Medline UNITE® MIS Foot Recon Screw System
Orthopedic
80d
Cleared
Oct 19, 2023
Medline UNITE® REFLEX® Nitinol Staple Kit
Orthopedic
30d
Cleared
Aug 09, 2023
Medline UNITE® REFLEX® Nitinol Staple System
Orthopedic
43d
Cleared
Sep 27, 2022
Medline UNITE® Medial Malleolus Peg Plate System
Orthopedic
139d
Cleared
Mar 22, 2022
Medline UNITE IM Fibula Implant
Orthopedic
28d
Cleared
Mar 02, 2022
Medline UNITE Calcaneal Fracture Plating System
Orthopedic
113d