Cardinalhealth

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
32
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252313Cardinal Health Nitrile Examination Gloves Extended CuffJanuary 14, 2026
K243660Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip August 22, 2025
K243652Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit ConnectDecember 19, 2024
K230569Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask WithJuly 3, 2023
K213174Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionMay 19, 2022
K202217Kendall NPWT Incision Management DeviceJune 4, 2021
K191101Kendall NPWT Incision Management Dressing KitJuly 31, 2020
K190923Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionNovember 7, 2019
K171499Occlusion Detection Dressing KitSeptember 22, 2017
K161418Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetJanuary 19, 2017
K150769Cardinal Health Trochanteric IM Nail SystemDecember 14, 2015
K150124Cardinal Health NPWT PRO HCSeptember 2, 2015
K150579Cardinal Health External Fixation SystemApril 29, 2015
K143016Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at HomeApril 20, 2015
K142916SVED Wound Treatment SystemMarch 4, 2015
K081464STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIESAugust 28, 2008
K080845ORWELL FLUID COLLECTION AND DISPOSAL SYSTEMApril 30, 2008
K072119AIRLIFE NEBULIZER CAPAugust 10, 2007
K053272CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVESJanuary 5, 2006
K052568ESTEEM STRETCHY VINYL GLOVE WITH COATINGNovember 28, 2005