Medical Device Manufacturer · US , Nortfield , IL

Medline Industries, LP

28 submissions · 28 cleared · Since 2022
28
Total
28
Cleared
0
Denied

Medline Industries, LP — FDA 510(k) Submissions

Medline Industries, LP has submitted 28 FDA 510(k) premarket notifications since 2022, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Staple, Fixation, Bone, Gown, Surgical, Humidifier, Respiratory Gas, (direct Patient Interface), Plate, Fixation, Bone, Wrap, Sterilization . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
Konig Bell Circumcision Clamp
K251687 · HFX Clamp, Circumcision · Obstetrics & Gynecology
Feb 2026 268d
Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
K253070 · DXC Clamp, Vascular · Cardiovascular
Nov 2025 58d
Medline Bag Decanter
K250345 · LHI Set, I.v. Fluid Transfer · General Hospital
Oct 2025 260d
Hudson RCI? Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI? Comfort Flo Plus and Soft Plus Cannula Extra Small
K250312 · BTT Humidifier, Respiratory... · Anesthesiology
Jul 2025 149d
Medline UNITE? REFLEX? Hybrid Nitinol Implant System
K243888 · JDR Staple, Fixation, Bone · Orthopedic
Apr 2025 114d
Medline Level 4 Surgical Gown with Breathable Sleeves
K242844 · FYA Gown, Surgical · General Hospital
Feb 2025 159d
Hudson RCI Comfort Flo? CubCannula?
K241778 · BTT Humidifier, Respiratory... · Anesthesiology
Dec 2024 182d
Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
K242370 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2024 132d
Hudson RCI? Comfort Flo Nasal Cannula; Hudson RCI? Comfort Flo Plus Cannula
K240163 · BTT Humidifier, Respiratory... · Anesthesiology
Sep 2024 249d
Medline Reusable Sterilization Wrappers
K234132 · FRG Wrap, Sterilization · General Hospital
Sep 2024 264d
Medline UNITE? MIS Foot Recon Screw System
K241359 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2024 80d
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/Dri-Tech Ventilator Accessory Extension Line
K234032 · BZE Heater, Breathing System... · Anesthesiology
Jun 2024 167d
PluroGel? Antimicrobial Burn and Wound Dressing, PluroGel? Burn and Wound Dressing (OTC)
K233151 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Mar 2024 181d
Medline Open-back Level 3 Protective Gown
K233526 · QPC Gown, Non-sterile,... · General Hospital
Mar 2024 125d
Medline Luer Lock Syringes
K230235 · FMF Syringe, Piston · General Hospital
Feb 2024 385d
Hudson RCI? AddiPak? Unit Dose Vial
K231058 · CAF Nebulizer (direct Patient... · Anesthesiology
Jan 2024 266d
Medline ComfortTemp Patient Warming System
K231211 · DWJ System, Thermal Regulating · Cardiovascular
Dec 2023 217d
Hudson RCI? TurboMist? Nebulizer System
K230602 · CAF Nebulizer (direct Patient... · Anesthesiology
Oct 2023 242d
Medline UNITE? REFLEX? Nitinol Staple Kit
K232905 · JDR Staple, Fixation, Bone · Orthopedic
Oct 2023 30d
Medline Safety Insulin and TB Syringes
K231907 · MEG Syringe, Antistick · General Hospital
Oct 2023 111d
Medline UNITE? REFLEX? Nitinol Staple System
K231885 · JDR Staple, Fixation, Bone · Orthopedic
Aug 2023 43d
Medline Surgical Face Mask and Medline Procedural Face Mask
K223236 · FXX Mask, Surgical · General Hospital
Mar 2023 156d
Gemini Sterilization Wrap
K220365 · FRG Wrap, Sterilization · General Hospital
Oct 2022 240d
Medline UNITE? Medial Malleolus Peg Plate System
K221360 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2022 139d
Medline Orbis LVL 3 Surgical Gown
K220333 · FYA Gown, Surgical · General Hospital
May 2022 103d
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All28 General Hospital 10 Orthopedic 7 Anesthesiology 6 Cardiovascular 2 General & Plastic Surgery 2 Obstetrics & Gynecology 1