Cardinal Health200, LLC
FDA 510(k) & PMA Approved Devices — 14 products
Total Devices14
Categories9
Latest FDA decision2024-08-23
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 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 |
No matching devices.