Company · US
Cardinal Health200, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2024. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FRG | Wrap, Sterilization | 11 |
| FYA | Gown, Surgical | 4 |
| FXX | Mask, Surgical | 3 |
| LZA | Polymer Patient Examination Glove | 2 |
| FYC | Gown, Isolation, Surgical | 1 |
| JOW | Sleeve, Limb, Compressible | 1 |
| KGO | Surgeon'S Gloves | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| MEG | Syringe, Antistick | 1 |
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 23, 2024 | K241780 | Cardinal Health Nitrile Exam Gloves Cardinal Health200, LLC | LZA |
| Jul 27, 2023 | K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets Cardinal Health200, LLC | FYA |
| Jun 21, 2023 | K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31 Cardinal Health200, LLC | MEG |
| Apr 3, 2023 | K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cardinal Health200, LLC | JOW |
| Sep 26, 2021 | K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove Cardinal Health200, LLC | KGO |
| Aug 28, 2021 | K211390 | Nitrile Blue Powder-free Examination Glove Cardinal Health200, LLC | LZA |
| Jul 29, 2020 | K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown Cardinal Health200, LLC | FYA |
| Mar 20, 2020 | K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Card Cardinal Health200, LLC | FYA |
| Dec 2, 2019 | K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip Cardinal Health200, LLC | FXX |
| Apr 26, 2019 | K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown Cardinal Health200, LLC | QPC |
| Dec 11, 2018 | K181174 | Cardinal Health Sterilization Wrap Cardinal Health200, LLC | FRG |
| Jun 9, 2017 | K170762 | Cardinal Health Non-Reinforced Surgical Gown Cardinal Health200, LLC | FYA |
| Apr 20, 2017 | K161910 | Cardinal Health Sterilization Wrap Cardinal Health200, LLC | FRG |
| Jul 28, 2016 | K160339 | Cardinal Health Isolation Gown Cardinal Health200, LLC | FYC |
| Dec 21, 2015 | K151445 | Cardinal Health Sterilization Wrap Cardinal Health200, LLC | FRG |
| Oct 30, 2015 | K151788 | Cardinal Health Sterilization Wrap Cardinal Health200, LLC | FRG |
| Mar 4, 2015 | K142990 | Insta-Gard Surgical and Procedure Face Mask Cardinal Health200, LLC | FXX |
| Jun 20, 2014 | K140155 | SECURE-GARD SURGICAL AND PROCEDURE FACE MASK Cardinal Health200, LLC | FXX |
| Jul 5, 2013 | K130404 | TIBURON SURGICAL DRAPE Cardinal Health200, LLC | KKX |
| Jun 18, 2013 | K130927 | DURABLUE STERILIZATION WRAP Cardinal Health200, LLC | FRG |
| Jan 23, 2013 | K123857 | DURABLUE STERILIZATION WRAP Cardinal Health200, LLC | FRG |
| Sep 26, 2012 | K122507 | DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION Cardinal Health200, LLC | FRG |
| Jun 13, 2012 | K120658 | DURABLUE STERILIZATION WRAP Cardinal Health200, LLC | FRG |
| Jan 20, 2012 | K112918 | DURABLUE STERILIZATION (AMSCO V-PRO) WRAP Cardinal Health200, LLC | FRG |
| Oct 20, 2011 | K112283 | DURA BLUE STERILIZATION WRAP Cardinal Health200, LLC | FRG |
| Oct 20, 2011 | K112211 | DURA BLUE STERILIZATION WRAP Cardinal Health200, LLC | FRG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||