Cardinal Health200, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 26
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241780 | Cardinal Health Nitrile Exam Gloves | August 23, 2024 |
| K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets | July 27, 2023 |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safe | June 21, 2023 |
| K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kend | April 3, 2023 |
| K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove | September 26, 2021 |
| K211390 | Nitrile Blue Powder-free Examination Glove | August 28, 2021 |
| K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgica | July 29, 2020 |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage G | March 20, 2020 |
| K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip | December 2, 2019 |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | April 26, 2019 |
| K181174 | Cardinal Health Sterilization Wrap | December 11, 2018 |
| K170762 | Cardinal Health Non-Reinforced Surgical Gown | June 9, 2017 |
| K161910 | Cardinal Health Sterilization Wrap | April 20, 2017 |
| K160339 | Cardinal Health Isolation Gown | July 28, 2016 |
| K151445 | Cardinal Health Sterilization Wrap | December 21, 2015 |
| K151788 | Cardinal Health Sterilization Wrap | October 30, 2015 |
| K142990 | Insta-Gard Surgical and Procedure Face Mask | March 4, 2015 |
| K140155 | SECURE-GARD SURGICAL AND PROCEDURE FACE MASK | June 20, 2014 |
| K130404 | TIBURON SURGICAL DRAPE | July 5, 2013 |
| K130927 | DURABLUE STERILIZATION WRAP | June 18, 2013 |