ClearanceBrief
Company · US

Cardinal Health

FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2022. Name variants (Inc, Corp, punctuation) are merged.

28510(k) clearances (0 in 12 months)
161recalls (0 in 12 months)
91recalls that name a 510(k)

Product codes

CodeDeviceRecords
FYAGown, Surgical51
KGOSurgeon'S Gloves21
LROGeneral Surgery Tray18
GAZTubing, Noninvasive10
FSMTray, Surgical, Instrument9
LZHPump, Infusion, Enteral7
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)6
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature4
LZAPolymer Patient Examination Glove4
KKXDrape, Surgical, Antimicrobial3
LRPTray, Surgical3
NBWSystem, Test, Blood Glucose, Over The Counter3
NGTSaline, Vascular Access Flush3
BZDVentilator, Non-Continuous (Respirator)2
FQMBandage, Elastic2
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2
KNWInstrument, Biopsy2
NDNCement, Bone, Vertebroplasty2
NVPHolding Chambers, Direct Patient Interface2
BSRStylet, Tracheal Tube1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 20, 2022K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml
Cardinal Health, LLC
LZH
Nov 23, 2021K211765Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
Cardinal Health, LLC
FYA
Jun 15, 2017K170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
Cardinal Health, Inc.
KGO
Jul 25, 2016K160411Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
Cardinal Health, Inc.
LYZ
Jul 11, 2016K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
Cardinal Health, Inc.
KGO
May 12, 2016K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy D
Cardinal Health, Inc.
KGO
Jan 31, 2013K122696POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
Cardinal Health, Inc.
LZA
Jul 27, 2012K121897PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
Cardinal Health, Inc.
KGO
May 23, 2012K120934PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
Cardinal Health, Inc.
KGO
Sep 29, 2011K111878PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
Cardinal Health, Inc.
KGO
Jun 8, 2011K110272STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG
Cardinal Health, Inc.
KGO
May 6, 2011K111015STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
Cardinal Health, Inc.
KGO
Apr 15, 2011K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Cardinal Health, Inc.
LZA
Dec 16, 2010K103249NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM
Cardinal Health, Inc.
LZA
Nov 4, 2010K102500STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
Cardinal Health, Inc.
KGO
Oct 15, 2010K101811PROTEGRITY SMT LATEX SURGICALGLOVES
Cardinal Health, Inc.
KGO
Jan 22, 2010K092684LAPAROSCOPIC RETRACTORS
Cardinal Health, Inc.
GCJ
Nov 18, 2009K090915STERILE WATER FOR INHALATION FLEX BAG, USP
Cardinal Health, Inc.
BTT
Oct 30, 2009K093300ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES
Cardinal Health, Inc.
KGO
Sep 15, 2009K092304ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES
Cardinal Health, Inc.
KGO
Jul 1, 2009K090211INFLATABLE BONE TAMP
Cardinal Health, Inc.
NDN
May 22, 2009K091250DIAGNOSTIC CATHETER SYSTEM
Cardinal Health, Inc.
EOQ
Mar 18, 2009K090272SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
Cardinal Health, Inc.
GZT
Dec 30, 2008K072964NICOLET CORTICAL STIMULATOR
Cardinal Health, Inc.
GYC
Nov 20, 2007K072133AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
Cardinal Health, Inc.
NDN
Jun 22, 2007K070647TRIFLEX SELECT
Cardinal Health, Inc.
KGO
Apr 18, 2007K070091COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208
Cardinal Health, Inc.
KNW
Aug 1, 2006K061762TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
Cardinal Health, Inc.
KKX

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patient.
Open, Classified		 FCMK903340
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient
Open, Classified		 FCMK903340
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
Open, Classified		 FCMK903340
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
Open, Classified		 FCMK903340
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
Open, Classified		 FCMK903340
Dec 2, 2022Cardinal Health
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
Open, Classified		 FCMK903340
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Open, Classified		 FYAK020593
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Open, Classified		 FYAK020593
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Open, Classified		 FYAK020593
Nov 2, 2021Cardinal Health
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Open, Classified		 FYAK020593
Nov 2, 2021Cardinal Health
Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
Open, Classified		 FYAK020593
Nov 2, 2021Cardinal Health
Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Open, Classified		 FYAK020593
Nov 2, 2021Cardinal Health
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Open, Classified		 FYAK020593
Nov 2, 2021Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Open, Classified		 FYAK023167
Nov 2, 2021Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
Open, Classified		 FYAK023167
Nov 2, 2021Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Open, Classified		 FYAK023167
Nov 2, 2021Cardinal Health
SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Open, Classified		 FYAK150151
Aug 4, 2021Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intr
Open, Classified		 NGTK032438
Aug 4, 2021Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling int
Open, Classified		 NGTK032438
Aug 4, 2021Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling in
Open, Classified		 NGTK032438
Mar 16, 2021Cardinal Health Inc.
ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
Open, Classified		 NBWK113137
Mar 16, 2021Cardinal Health Inc.
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
Open, Classified		 NVPK110293
Mar 16, 2021Cardinal Health Inc.
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
Open, Classified		 FMKNone listed
Mar 16, 2021Cardinal Health Inc.
ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
Open, Classified		 FMKNone listed
Mar 16, 2021Cardinal Health Inc.
ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
Open, Classified		 NBWK062195
Mar 16, 2021Cardinal Health Inc.
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Open, Classified		 FMKNone listed
Mar 16, 2021Cardinal Health Inc.
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
Open, Classified		 NBWK062195
Mar 16, 2021Cardinal Health Inc.
VAPORIZER VICKS 1.5GAL Item Number: 2354942
Open, Classified		 KFZK950116
Mar 16, 2021Cardinal Health Inc.
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Open, Classified		 QBJK200876
Mar 16, 2021Cardinal Health Inc.
BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
Open, Classified		 FMIK162516
Mar 16, 2021Cardinal Health Inc.
AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
Open, Classified		 NVPK181649
Mar 16, 2021Cardinal Health Inc.
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Open, Classified		 QLGK193371
Mar 16, 2021Cardinal Health Inc.
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Open, Classified		 PZENone listed
Mar 16, 2021Cardinal Health Inc.
FREESTYLE LANCETS 28G 100CT Item Number:2975670
Open, Classified		 FMKNone listed
Apr 20, 2020Cardinal Health Inc.
Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant w
Terminated		 PQZK170586
Apr 20, 2020Cardinal Health Inc.
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which ar
Terminated		 JJWNone listed
Apr 20, 2020Cardinal Health Inc.
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
Terminated		 JINNone listed
Jan 24, 2020Cardinal Health
AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511
Terminated		 FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
Terminated		 FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
Terminated		 FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
Terminated		 FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL
Terminated		 FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541
Terminated		 FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511
Terminated		 FYAK020593
Jan 24, 2020Cardinal Health
AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545
Terminated		 FYAK170762
Jan 24, 2020Cardinal Health
GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
Terminated		 FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995
Terminated		 FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
Terminated		 FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
Terminated		 FYAK170762
Jan 24, 2020Cardinal Health
AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575
Terminated		 FYAK170762

Newest 50 of 161.

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