FDA 510(k) Applications Submitted by Cardinal Health

FDA 510(k) Number Submission Date Device Name Applicant
K190923 04/09/2019 Salem Sump Dual Lumen Stomach Tube with ENFit Connection Cardinal Health
K052568 09/19/2005 ESTEEM STRETCHY VINYL GLOVE WITH COATING Cardinal Health
K053272 11/23/2005 CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES Cardinal Health
K171499 05/23/2017 Occlusion Detection Dressing Kit Cardinal Health
K230569 03/01/2023 Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) Cardinal Health
K191101 04/25/2019 Kendall NPWT Incision Management Dressing Kit Cardinal Health
K202217 08/06/2020 Kendall NPWT Incision Management Device Cardinal Health
K031301 04/24/2003 ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING Cardinal Health
K032444 08/08/2003 NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY Cardinal Health
K042574 09/22/2004 ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) Cardinal Health
K033789 12/04/2003 LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING Cardinal Health
K033905 12/17/2003 PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING Cardinal Health
K161418 05/23/2016 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set CARDINAL HEALTH
K031468 05/09/2003 TEMPORARY TITANIUM ANEURYSM CLIP Cardinal Health
K080845 03/26/2008 ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM Cardinal Health
K041418 05/27/2004 AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER Cardinal Health
K213174 09/28/2021 Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection Cardinal Health
K040152 01/23/2004 BONE CEMENT FOR CRANIOPLASTY Cardinal Health
K050994 04/19/2005 AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM Cardinal Health
K051226 05/12/2005 AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER Cardinal Health
K072119 08/01/2007 AIRLIFE NEBULIZER CAP Cardinal Health
K032388 08/04/2003 BONE CEMENT RADIO-OPACIFIER Cardinal Health
K043518 12/20/2004 RADIOPAQUE BONE CEMENT Cardinal Health
K081464 05/27/2008 STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES Cardinal Health
K150124 01/20/2015 Cardinal Health NPWT PRO HC CARDINAL HEALTH
K150579 03/09/2015 Cardinal Health External Fixation System CARDINAL HEALTH
K150769 03/24/2015 Cardinal Health Trochanteric IM Nail System Cardinal Health
K142916 10/07/2014 SVED Wound Treatment System CARDINAL HEALTH
K143016 10/20/2014 Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home CARDINAL HEALTH


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