Company · US
Cardinalhealth
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 7 |
| KGO | Surgeon'S Gloves | 4 |
| LZC | Medical Glove, Specialty | 3 |
| BZD | Ventilator, Non-Continuous (Respirator) | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 2 |
| FMF | Syringe, Piston | 1 |
| FXX | Mask, Surgical | 1 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 |
| HCH | Clip, Aneurysm | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 |
| LYY | Latex Patient Examination Glove | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 |
| LZA | Polymer Patient Examination Glove | 1 |
| MYU | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty | 1 |
| NDN | Cement, Bone, Vertebroplasty | 1 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2026 | K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Cardinalhealth | LZA |
| Jan 14, 2026 | K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff Cardinalhealth | LZC |
| Aug 22, 2025 | K243660 | Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoje Cardinalhealth | FMF |
| Dec 19, 2024 | K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Cardinalhealth | PNR |
| Jul 3, 2023 | K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel Cardinalhealth | FXX |
| May 19, 2022 | K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection Cardinalhealth | PIF |
| Jun 4, 2021 | K202217 | Kendall NPWT Incision Management Device Cardinalhealth | OMP |
| Jul 31, 2020 | K191101 | Kendall NPWT Incision Management Dressing Kit Cardinalhealth | OMP |
| Nov 7, 2019 | K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection Cardinalhealth | PIF |
| Sep 22, 2017 | K171499 | Occlusion Detection Dressing Kit Cardinalhealth | OMP |
| Jan 19, 2017 | K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set Cardinalhealth | OMP |
| Dec 14, 2015 | K150769 | Cardinal Health Trochanteric IM Nail System Cardinalhealth | HSB |
| Sep 2, 2015 | K150124 | Cardinal Health NPWT PRO HC Cardinalhealth | OMP |
| Apr 29, 2015 | K150579 | Cardinal Health External Fixation System Cardinalhealth | KTT |
| Apr 20, 2015 | K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home Cardinalhealth | OMP |
| Mar 4, 2015 | K142916 | SVED Wound Treatment System Cardinalhealth | OMP |
| Aug 28, 2008 | K081464 | STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES Cardinalhealth | LYY |
| Apr 30, 2008 | K080845 | ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM Cardinalhealth | JCX |
| Aug 10, 2007 | K072119 | AIRLIFE NEBULIZER CAP Cardinalhealth | CAF |
| Jan 5, 2006 | K053272 | CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES Cardinalhealth | KGO |
| Nov 28, 2005 | K052568 | ESTEEM STRETCHY VINYL GLOVE WITH COATING Cardinalhealth | LYZ |
| Nov 17, 2005 | K051226 | AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER Cardinalhealth | BZD |
| Aug 3, 2005 | K050994 | AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM Cardinalhealth | BZD |
| May 11, 2005 | K043518 | RADIOPAQUE BONE CEMENT Cardinalhealth | NDN |
| Dec 8, 2004 | K042574 | ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) Cardinalhealth | KGO |
| Jun 10, 2004 | K041418 | AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER Cardinalhealth | CAF |
| May 19, 2004 | K040152 | BONE CEMENT FOR CRANIOPLASTY Cardinalhealth | GXP |
| May 7, 2004 | K033789 | LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING Cardinalhealth | LZC |
| Apr 27, 2004 | K033905 | PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING Cardinalhealth | KGO |
| Nov 13, 2003 | K032444 | NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY Cardinalhealth | LZC |
| Oct 31, 2003 | K032388 | BONE CEMENT RADIO-OPACIFIER Cardinalhealth | MYU |
| Oct 15, 2003 | K031301 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING Cardinalhealth | KGO |
| Jun 20, 2003 | K031468 | TEMPORARY TITANIUM ANEURYSM CLIP Cardinalhealth | HCH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||