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Cardinal Health200, LLC

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories9
Latest Approval2024-08-23
TypeNumberDevice NameCodeDate
510(k) K241780 Cardinal Health Nitrile Exam Gloves LZA 2024-08-23 View
510(k) K230838 Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets FYA 2023-07-27 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) MEG 2023-06-21 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 Assembly JOW 2023-04-03 View
510(k) K201592 Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove KGO 2021-09-26 View
510(k) K211390 Nitrile Blue Powder-free Examination Glove LZA 2021-08-28 View
510(k) K200824 Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown FYA 2020-07-29 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 Sleeve FYA 2020-03-20 View
510(k) K192374 Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip FXX 2019-12-02 View
510(k) K182830 Cardinal HealthTM Poly-Coated Open-Back Protective Gown QPC 2019-04-26 View
510(k) K181174 Cardinal Health Sterilization Wrap FRG 2018-12-11 View
510(k) K170762 Cardinal Health Non-Reinforced Surgical Gown FYA 2017-06-09 View
510(k) K161910 Cardinal Health Sterilization Wrap FRG 2017-04-20 View
510(k) K160339 Cardinal Health Isolation Gown FYC 2016-07-28 View
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