Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Cardinal Health200, LLC

FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K241780 Cardinal Health Nitrile Exam GlovesLZA2024-08-23 View
510(k) K230838 Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument PocketsFYA2023-07-27 View
510(k) K223376 Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)MEG2023-06-21 View
510(k) K230028 Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing AssemblyJOW2023-04-03 View
510(k) K201592 Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloveKGO2021-09-26 View
510(k) K211390 Nitrile Blue Powder-free Examination GloveLZA2021-08-28 View
510(k) K200824 Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical GownFYA2020-07-29 View
510(k) K193327 Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage SleeveFYA2020-03-20 View
510(k) K192374 Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam StripFXX2019-12-02 View
510(k) K182830 Cardinal HealthTM Poly-Coated Open-Back Protective GownQPC2019-04-26 View
510(k) K181174 Cardinal Health Sterilization WrapFRG2018-12-11 View
510(k) K170762 Cardinal Health Non-Reinforced Surgical GownFYA2017-06-09 View
510(k) K161910 Cardinal Health Sterilization WrapFRG2017-04-20 View
510(k) K160339 Cardinal Health Isolation GownFYC2016-07-28 View
510(k) K130404 TIBURON SURGICAL DRAPEKKX2013-07-05 View
510(k) K130927 DURABLUE STERILIZATION WRAPFRG2013-06-18 View
510(k) K123857 DURABLUE STERILIZATION WRAPFRG2013-01-23 View
510(k) K122507 DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATIONFRG2012-09-26 View
510(k) K120658 DURABLUE STERILIZATION WRAPFRG2012-06-13 View
510(k) K112918 DURABLUE STERILIZATION (AMSCO V-PRO) WRAPFRG2012-01-20 View
↑