Medical Device Manufacturer · US , Mchenry , IL

Medline Industries, Inc.

238 submissions · 234 cleared · Since 1977
238
Total
234
Cleared
1
Denied

Medline Industries, Inc. — FDA 510(k) Submissions

Medline Industries, Inc. has submitted 238 FDA 510(k) premarket notifications since 1977, of which 234 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Polymer Patient Examination Glove, Gown, Surgical, Surgeon's Gloves, Wrap, Sterilization, Vehicle, Motorized 3-wheeled . Use the specialty filter in the sidebar to narrow results.

238 devices
1–25 of 238
Medline ART Skin Harvesting System
DEN210049 · QYK Semi-automated Autologous... · General & Plastic Surgery
Mar 2024 890d
Hudson RCI? Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI? Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
K230559 · BTT Humidifier, Respiratory... · Anesthesiology
Oct 2023 240d
Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
K223100 · CAF Nebulizer (direct Patient... · Anesthesiology
Jun 2023 270d
Medline UNITE? Ankle Fusion Plating System
K222665 · HRS Plate, Fixation, Bone · Orthopedic
Jan 2023 141d
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
K213054 · FMF Syringe, Piston · General Hospital
Dec 2022 443d
Konig Mogen Clamp
K212911 · HFX Clamp, Circumcision · Obstetrics & Gynecology
Nov 2022 431d
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
K220565 · BWF Spirometer, Therapeutic... · Anesthesiology
Oct 2022 239d
Medline General Surgery Tray
K213481 · LRO General Surgery Tray · General & Plastic Surgery
May 2022 207d
Medline Universal Grounding Pad
K212093 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2022 192d
Medline Smoke Evacuation Shroud
K213068 · FYD Apparatus, Exhaust, Surgical · General Hospital
Jan 2022 102d
Medline UNITE REFLEX Dynamic Discs
K211612 · HTN Washer, Bolt Nut · Orthopedic
Dec 2021 198d
Medline Cardiovascular Procedure Kit
K212258 · LRO General Surgery Tray · General & Plastic Surgery
Dec 2021 136d
Medline Digital Thermometer Non-Lubricated Probe Sheath
K211931 · FLL Continuous Measurement... · General Hospital
Sep 2021 90d
SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
K203538 · KGO Surgeon's Gloves · General Hospital
Aug 2021 242d
Medline UNITE? Digital Fusion Screw System
K211944 · HWC Screw, Fixation, Bone · Orthopedic
Jul 2021 29d
Medline Vacu-line Suction Aspirator
K203135 · BTA Pump, Portable,... · General & Plastic Surgery
May 2021 197d
Medline UNITE REFLEX Nitinol Staple System
K210482 · JDR Staple, Fixation, Bone · Orthopedic
Apr 2021 62d
Medline Orbis Surgical Gown
K202447 · FYA Gown, Surgical · General Hospital
Apr 2021 219d
Medline Cautery Tip Cleaner
K210526 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2021 17d
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50?g/dm2 per Glove of Extractable Protein
K202668 · KGO Surgeon's Gloves · General Hospital
Dec 2020 96d
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50?g/dm? per glove of Extractable Protein
K202449 · KGO Surgeon's Gloves · General Hospital
Nov 2020 84d
Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
K200150 · LZA Polymer Patient... · General Hospital
Oct 2020 278d
Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)
K202179 · LYZ Vinyl Patient Examination... · General Hospital
Oct 2020 83d
Medline ENfit OTC Feeding Syringe
K202285 · PNR Enteral Syringes With... · Gastroenterology & Urology
Oct 2020 58d
Medline DeNovo 4Pro Electrical Stimulation Device
K201290 · IPF Stimulator, Muscle, Powered · Physical Medicine
Sep 2020 130d

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