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Cardinalhealth

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories7
Latest FDA decision2026-01-14
TypeNumberDevice NameCodeDateActions
510(k) K252313 Cardinal Health Nitrile Examination Gloves Extended CuffLZC2026-01-14 View
510(k) K243660 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); MonojecFMF2025-08-22 View
510(k) K243652 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)PNR2024-12-19 View
510(k) K230569 Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )FXX2023-07-03 View
510(k) K213174 Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionPIF2022-05-19 View
510(k) K202217 Kendall NPWT Incision Management DeviceOMP2021-06-04 View
PMA P190007 Automated external defibrillators (non-wearable)MKJ2020-08-07 View
510(k) K191101 Kendall NPWT Incision Management Dressing KitOMP2020-07-31 View
510(k) K190923 Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionPIF2019-11-07 View
510(k) K171499 Occlusion Detection Dressing KitOMP2017-09-22 View
510(k) K161418 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetOMP2017-01-19 View
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