FDA 510(k) Applications Submitted by Cardinal Health, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070647 |
03/08/2007 |
TRIFLEX SELECT |
CARDINAL HEALTH, INC. |
| K072964 |
10/19/2007 |
NICOLET CORTICAL STIMULATOR |
CARDINAL HEALTH, INC. |
| K090272 |
02/04/2009 |
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) |
CARDINAL HEALTH, INC. |
| K090915 |
04/01/2009 |
STERILE WATER FOR INHALATION FLEX BAG, USP |
CARDINAL HEALTH, INC. |
| K061762 |
06/22/2006 |
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N |
CARDINAL HEALTH, INC. |
| K170198 |
01/23/2017 |
Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) |
Cardinal Health, Inc. |
| K160411 |
02/16/2016 |
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating |
CARDINAL HEALTH, INC. |
| K160875 |
03/30/2016 |
Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating |
CARDINAL HEALTH, INC. |
| K153316 |
11/17/2015 |
Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) |
Cardinal Health, Inc. |
| K070091 |
01/10/2007 |
COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208 |
CARDINAL HEALTH, INC. |
| K090211 |
01/28/2009 |
INFLATABLE BONE TAMP |
CARDINAL HEALTH, INC. |
| K091250 |
04/28/2009 |
DIAGNOSTIC CATHETER SYSTEM |
CARDINAL HEALTH, INC. |
| K072133 |
08/02/2007 |
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE |
CARDINAL HEALTH, INC. |
| K092684 |
09/01/2009 |
LAPAROSCOPIC RETRACTORS |
CARDINAL HEALTH, INC. |
| K110272 |
01/31/2011 |
STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG |
CARDINAL HEALTH, INC. |
| K120934 |
03/28/2012 |
PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS |
CARDINAL HEALTH, INC. |
| K110921 |
04/01/2011 |
NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
CARDINAL HEALTH, INC. |
| K111015 |
04/11/2011 |
STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING |
CARDINAL HEALTH, INC. |
| K101811 |
06/29/2010 |
PROTEGRITY SMT LATEX SURGICALGLOVES |
CARDINAL HEALTH, INC. |
| K121897 |
06/29/2012 |
PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES |
CARDINAL HEALTH, INC. |
| K111878 |
07/01/2011 |
PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES |
CARDINAL HEALTH, INC. |
| K092304 |
07/29/2009 |
ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES |
CARDINAL HEALTH, INC. |
| K102500 |
09/01/2010 |
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING |
CARDINAL HEALTH, INC. |
| K122696 |
09/04/2012 |
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) |
CARDINAL HEALTH, INC. |
| K093300 |
10/21/2009 |
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES |
CARDINAL HEALTH, INC. |
| K103249 |
11/03/2010 |
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM |
CARDINAL HEALTH, INC. |
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