Cardinalhealth is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Cardinalhealth - FDA 510(k) Cleared Devices
Recent clearances: Cardinal Health Nitrile Examination Gloves Extended Cuff, Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777), Monoject™ Enteral Syringe with ENFit Connector (401SE)
32
Total
32
Cleared
0
Denied
Cardinalhealth has 32 FDA 510(k) cleared medical devices. Based in Mcgaw Park, US.
Latest FDA clearance: Jan 2026. Active since 2003.
Browse the FDA 510(k) cleared devices submitted by Cardinalhealth Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Patient Recovery, Cardinal Health and Cardinal Health200, LLC.
FDA 510(k) Regulatory Record - Cardinalhealth
32 devices
Cleared
Jan 14, 2026
Cardinal Health Nitrile Examination Gloves Extended Cuff
General Hospital
173d
Cleared
Aug 22, 2025
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777)
General Hospital
268d
Cleared
Dec 19, 2024
Monoject™ Enteral Syringe with ENFit Connector (401SE)
Gastroenterology & Urology
23d
Cleared
Jul 03, 2023
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 )
General Hospital
124d
Cleared
May 19, 2022
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
Gastroenterology & Urology
233d
Cleared
Jun 04, 2021
Kendall NPWT Incision Management Device
General & Plastic Surgery
302d
Cleared
Jul 31, 2020
Kendall NPWT Incision Management Dressing Kit
General & Plastic Surgery
463d
Cleared
Nov 07, 2019
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
Gastroenterology & Urology
212d
Cleared
Sep 22, 2017
Occlusion Detection Dressing Kit
General & Plastic Surgery
122d
Cleared
Jan 19, 2017
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation...
General & Plastic Surgery
241d
Cleared
Dec 14, 2015
Cardinal Health Trochanteric IM Nail System
Orthopedic
265d
Cleared
Sep 02, 2015
Cardinal Health NPWT PRO HC
General & Plastic Surgery
225d