Medical Device Manufacturer · US , Mcgaw Park , IL

Cardinalhealth

32 submissions · 32 cleared · Since 2003
32
Total
32
Cleared
0
Denied

Cardinalhealth — FDA 510(k) Submissions

Cardinalhealth has submitted 32 FDA 510(k) premarket notifications since 2003, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Negative Pressure Wound Therapy Powered Suction Pump, Surgeon's Gloves, Medical Glove, Specialty, Gastrointestinal Tubes With Enteral Specific Connectors, Nebulizer (direct Patient Interface) . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
Cardinal Health Nitrile Examination Gloves Extended Cuff
K252313 · LZC Medical Glove, Specialty · General Hospital
Jan 2026 173d
Monoject? 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject? 3mL Syringe, Luer-Lock Tip (1180300777); Monoject? 6mL Syringe, Luer-Lock Tip (1180600777); Monoject? 12mL Syringe, Luer-Lock Tip (1181200777); Monoject? 20mL Syringe, Luer-Lock Tip (1182000777); Monoject? 35mL Syringe, Luer-Lock Tip (1183500777); Monoject? 60mL Syringe, Luer-Lock Tip (1186000777); Monoject? 3mL Syringe, Luer-Lock Tip (8881513934); Monoject? 6mL Syringe , Luer-Lock Tip (8881516937); Monojec
K243660 · FMF Syringe, Piston · General Hospital
Aug 2025 268d
Monoject? Enteral Syringe with ENFit Connector (401SE); Monoject? Enteral Syringe with ENFit Connector (403SE); Monoject? Enteral Syringe with ENFit Connector (406SE); Monoject? Enteral Syringe with ENFit Connector (412SE); Monoject? Enteral Syringe with ENFit Connector (435SE); Monoject? Enteral Syringe with ENFit Connector (460SE)
K243652 · PNR Enteral Syringes With... · Gastroenterology & Urology
Dec 2024 23d
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
K230569 · FXX Mask, Surgical · General Hospital
Jul 2023 124d
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
K213174 · PIF Gastrointestinal Tubes... · Gastroenterology & Urology
May 2022 233d
Kendall NPWT Incision Management Device
K202217 · OMP Negative Pressure Wound... · General & Plastic Surgery
Jun 2021 302d
Kendall NPWT Incision Management Dressing Kit
K191101 · OMP Negative Pressure Wound... · General & Plastic Surgery
Jul 2020 463d
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
K190923 · PIF Gastrointestinal Tubes... · Gastroenterology & Urology
Nov 2019 212d
Occlusion Detection Dressing Kit
K171499 · OMP Negative Pressure Wound... · General & Plastic Surgery
Sep 2017 122d
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
K161418 · OMP Negative Pressure Wound... · General & Plastic Surgery
Jan 2017 241d
Cardinal Health Trochanteric IM Nail System
K150769 · HSB Rod, Fixation,... · Orthopedic
Dec 2015 265d
Cardinal Health NPWT PRO HC
K150124 · OMP Negative Pressure Wound... · General & Plastic Surgery
Sep 2015 225d
Cardinal Health External Fixation System
K150579 · KTT Appliance, Fixation,... · Orthopedic
Apr 2015 51d
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home
K143016 · OMP Negative Pressure Wound... · General & Plastic Surgery
Apr 2015 182d
SVED Wound Treatment System
K142916 · OMP Negative Pressure Wound... · General & Plastic Surgery
Mar 2015 148d
STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
K081464 · LYY Latex Patient Examination... · General Hospital
Aug 2008 93d
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
K080845 · JCX Apparatus, Suction, Ward... · General & Plastic Surgery
Apr 2008 35d
AIRLIFE NEBULIZER CAP
K072119 · CAF Nebulizer (direct Patient... · Anesthesiology
Aug 2007 9d
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
K053272 · KGO Surgeon's Gloves · General Hospital
Jan 2006 43d
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · LYZ Vinyl Patient Examination... · General Hospital
Nov 2005 70d
AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
K051226 · BZD Ventilator,... · Anesthesiology
Nov 2005 189d
AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K050994 · BZD Ventilator,... · Anesthesiology
Aug 2005 106d
RADIOPAQUE BONE CEMENT
K043518 · NDN Cement, Bone, Vertebroplasty · Orthopedic
May 2005 142d
ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)
K042574 · KGO Surgeon's Gloves · General Hospital
Dec 2004 77d
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
K041418 · CAF Nebulizer (direct Patient... · Anesthesiology
Jun 2004 14d
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