Cardinalhealth
Mcgaw Park, IL, US
Cardinalhealth appears in FDA device records in Mcgaw Park, IL. FDA records list 32 510(k) clearances between and , one PMA record and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 32
- PMA records
- 1
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for Cardinalhealth between 2003 and 2026. The busiest year on record is 2004, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 4 |
| 2004 | 5 |
| 2005 | 4 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2015 | 5 |
| 2017 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff | LZC | Substantially Equivalent | |
| K243660 | Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | FMF | Substantially Equivalent | |
| K243652 | Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) | PNR | Substantially Equivalent | |
| K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) | FXX | Substantially Equivalent | |
| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | PIF | Substantially Equivalent | |
| K202217 | Kendall NPWT Incision Management Device | OMP | Substantially Equivalent | |
| K191101 | Kendall NPWT Incision Management Dressing Kit | OMP | Substantially Equivalent | |
| K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | PIF | Substantially Equivalent | |
| K171499 | Occlusion Detection Dressing Kit | OMP | Substantially Equivalent | |
| K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set | OMP | Substantially Equivalent | |
| K150769 | Cardinal Health Trochanteric IM Nail System | HSB | Substantially Equivalent | |
| K150124 | Cardinal Health NPWT PRO HC | OMP | Substantially Equivalent | |
| K150579 | Cardinal Health External Fixation System | KTT | Substantially Equivalent | |
| K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home | OMP | Substantially Equivalent | |
| K142916 | SVED Wound Treatment System | OMP | Substantially Equivalent | |
| K081464 | STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES | LYY | Substantially Equivalent | |
| K080845 | ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM | JCX | Substantially Equivalent | |
| K072119 | AIRLIFE NEBULIZER CAP | CAF | Substantially Equivalent | |
| K053272 | CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K052568 | ESTEEM STRETCHY VINYL GLOVE WITH COATING | LYZ | Substantially Equivalent | |
| K051226 | AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER | BZD | Substantially Equivalent | |
| K050994 | AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | BZD | Substantially Equivalent | |
| K043518 | RADIOPAQUE BONE CEMENT | NDN | Substantially Equivalent | |
| K042574 | ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) | KGO | Substantially Equivalent | |
| K041418 | AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER | CAF | Substantially Equivalent | |
| K040152 | BONE CEMENT FOR CRANIOPLASTY | GXP | Substantially Equivalent | |
| K033789 | LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING | LZC | Substantially Equivalent | |
| K033905 | PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING | KGO | Substantially Equivalent | |
| K032444 | NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY | LZC | Substantially Equivalent | |
| K032388 | BONE CEMENT RADIO-OPACIFIER | MYU | Substantially Equivalent | |
| K031301 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING | KGO | Substantially Equivalent | |
| K031468 | TEMPORARY TITANIUM ANEURYSM CLIP | HCH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- MKJAutomated External Defibrillators (Non-Wearable)
- NDNCement, Bone, Vertebroplasty
- HCHClip, Aneurysm
- PNREnteral Syringes With Enteral Specific Connectors
- PIFGastrointestinal Tubes With Enteral Specific Connectors
- LYYLatex Patient Examination Glove
- FXXMask, Surgical
- LZCMedical Glove, Specialty
- GXPMethyl Methacrylate For Cranioplasty
- CAFNebulizer (Direct Patient Interface)
- OMPNegative Pressure Wound Therapy Powered Suction Pump
- HSBRod, Fixation, Intramedullary And Accessories
- KGOSurgeon'S Gloves
- FMFSyringe, Piston
- BZDVentilator, Non-Continuous (Respirator)
- LYZVinyl Patient Examination Glove
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain