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Data / Medical devices / United States / Cardinal Health

Cardinal Health: FDA-registered device maker in Hazelwood, MO, United States, 207 510(k) clearances and 1 PMA approval

Cardinal Health is registered with the FDA (registration 1921846) in Hazelwood, MO, United States. It lists 164 device types. The FDA files 207 510(k) clearances and 1 PMA approval under its listings, the newest dated September 2, 2026. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this oneWatch Cardinal Health
FDA registration number
1921846
Address
444 James South Mcdonnell BLVD., Hazelwood, MO, United States, 63042
Owner or operator
Cardinal Health 200, LLC (9028292)
Roles
Specification developer
First device listed
December 23, 1977
Registered through
2027
Brand names listed
CARDINAL HEALTH NITRILE EXAMINATION GLOVES EXTENDED CUFF, Stainless Steel Tongue Cleaner

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Specification developeraccessdata.fda.gov
Accessories, Catheter, G-UKNY2Specification developeraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Specification developeraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Specification developeraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Specification developeraccessdata.fda.gov
Automated External Defibrillators (Non-Wearable)MKJ3Specification developeraccessdata.fda.gov
Bag, IceKYR1Specification developeraccessdata.fda.gov
Bag, IntestineKGY1Specification developeraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Specification developeraccessdata.fda.gov
Bandage, CastITG1Specification developeraccessdata.fda.gov
Bandage, ElasticFQM1Specification developeraccessdata.fda.gov
Bandage, LiquidKMF1Specification developeraccessdata.fda.gov
Basin, EmesisFNY1Specification developeraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Specification developeraccessdata.fda.gov
Binder, AbdominalFSD1Specification developeraccessdata.fda.gov
Board, Arm (With Cover), SterileBTX1Specification developeraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Specification developeraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Specification developeraccessdata.fda.gov
Cable, ElectrodeIKD2Specification developeraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Specification developeraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Specification developeraccessdata.fda.gov
Cap, SurgicalFYF1Specification developeraccessdata.fda.gov
Cardiovascular Surgical Instruments TrayOFA1Specification developeraccessdata.fda.gov
Catheter (Gastric, Colonic, Etc.), Irrigation And AspirationKDH2Specification developeraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Specification developeraccessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF2Specification developeraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS2Specification developeraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Specification developeraccessdata.fda.gov
Catheter, IrrigationGBX1Specification developeraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Specification developeraccessdata.fda.gov
Catheter, StraightEZD2Specification developeraccessdata.fda.gov
Catheter, Umbilical ArteryFOS2Specification developeraccessdata.fda.gov
Catheter, UrethralGBM2Specification developeraccessdata.fda.gov
Catheter, UrologicalKOD2Specification developeraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Specification developeraccessdata.fda.gov
Clamp, CircumcisionHFX2Specification developeraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Specification developeraccessdata.fda.gov
Clinical Electronic ThermometerSDV2Specification developeraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Specification developeraccessdata.fda.gov
Connector, CatheterGCD1Specification developeraccessdata.fda.gov
Container, I.V.KPE2Specification developeraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Specification developeraccessdata.fda.gov
Container, SharpsMMK2Specification developeraccessdata.fda.gov
Container, Specimen Mailer And Storage, SterileKDT1Specification developeraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Specification developeraccessdata.fda.gov
Container, Specimen, SterileFMH1Specification developeraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Specification developeraccessdata.fda.gov
Counter, Sponge, SurgicalLWH1Specification developeraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Specification developeraccessdata.fda.gov
Curette, Suction, Endometrial (And Accessories)HHK2Specification developeraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Specification developeraccessdata.fda.gov
Device, BiofeedbackHCC2Specification developeraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Specification developeraccessdata.fda.gov
Device, Incontinence, Urosheath Type, SterileEXJ1Specification developeraccessdata.fda.gov
Device, Occlusion, UmbilicalFOD1Specification developeraccessdata.fda.gov
Device, Urine Flow Rate Measuring, Non-Electrical, DisposableFFG2Specification developeraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Specification developeraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Specification developeraccessdata.fda.gov
Douche Apparatus, Vaginal, TherapeuticHED1Specification developeraccessdata.fda.gov
Drape, Microscope, OphthalmicHMW2Specification developeraccessdata.fda.gov
Drape, Patient, OphthalmicHMT2Specification developeraccessdata.fda.gov
Drape, Pure Latex Sheet, With Self-Retaining Finger CotEYX2Specification developeraccessdata.fda.gov
Drape, Surgical, EntERY2Specification developeraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Specification developeraccessdata.fda.gov
Drape, Urological, DisposableEYY2Specification developeraccessdata.fda.gov
Dressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicMGQUSpecification developeraccessdata.fda.gov
Dressing, Wound, DrugFROUSpecification developeraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Specification developeraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Specification developeraccessdata.fda.gov
Electrode, Circular (Spiral), Scalp And ApplicatorHGP2Specification developeraccessdata.fda.gov
Electrode, CutaneousGXY2Specification developeraccessdata.fda.gov
Electrode, ElectrocardiographDRX2Specification developeraccessdata.fda.gov
Electrode, Electrocardiograph, Multi-FunctionMLN2Specification developeraccessdata.fda.gov
Enema KitFCE1Specification developeraccessdata.fda.gov
Enteral Administration Kit (Adult & Pediatric)PRM2Specification developeraccessdata.fda.gov
Enteral Syringes With Enteral Specific ConnectorsPNR2Specification developeraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Specification developeraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Specification developeraccessdata.fda.gov
Fentanyl And Other Opioid Protection GloveQDO1Specification developeraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Specification developeraccessdata.fda.gov
Foley Catheter Kit (Excludes Hiv Testing)PPB2Specification developeraccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Specification developeraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Specification developeraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Specification developeraccessdata.fda.gov
Gauze/Sponge, InternalEFQUSpecification developeraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Specification developeraccessdata.fda.gov
General Surgery TrayLRO2Specification developeraccessdata.fda.gov
Gown, Isolation, SurgicalFYC2Specification developeraccessdata.fda.gov
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier ProtectionQPC2Specification developeraccessdata.fda.gov
Gown, SurgicalFYA2Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Specification developeraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Specification developeraccessdata.fda.gov
Instrument, BiopsyKNW2Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Specification developeraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Specification developeraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Specification developeraccessdata.fda.gov
Introducer, CatheterDYB2Specification developeraccessdata.fda.gov
Labor And Delivery KitMLS2Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Specification developeraccessdata.fda.gov
Light, Surgical, Ceiling MountedFSY2Specification developeraccessdata.fda.gov
Lubricant, PatientKMJ1Specification developeraccessdata.fda.gov
Lumbar Puncture Tray (Adult & Pediatric)PWY2Specification developeraccessdata.fda.gov
Manometer, Spinal-FluidFMJ2Specification developeraccessdata.fda.gov
Marker, SkinFZZ1Specification developeraccessdata.fda.gov
Mask, SurgicalFXX2Specification developeraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Specification developeraccessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsOPJ1Specification developeraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Specification developeraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Specification developeraccessdata.fda.gov
Needle, DentalDZM1Specification developeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Specification developeraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Specification developeraccessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction PumpOMP2Specification developeraccessdata.fda.gov
Non-Surgical GownOEA1Specification developeraccessdata.fda.gov
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)DRO2Specification developeraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Specification developeraccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBUSpecification developeraccessdata.fda.gov
Pad, EyeHMP1Specification developeraccessdata.fda.gov
Pad, Neonatal EyeFOK1Specification developeraccessdata.fda.gov
Peripheral Catheter Insertion KitOWL2Specification developeraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Specification developeraccessdata.fda.gov
Pump, InfusionFRN2Specification developeraccessdata.fda.gov
Pump, Infusion, EnteralLZH2Specification developeraccessdata.fda.gov
Razor, SurgicalLWK1Specification developeraccessdata.fda.gov
Recorder, Paper ChartDSF1Specification developeraccessdata.fda.gov
Ring (Wound Protector), Drape Retention, InternalKGW2Specification developeraccessdata.fda.gov
Scalpel, One-PieceGDX1Specification developeraccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Specification developeraccessdata.fda.gov
Solvent, Adhesive TapeKOX1Specification developeraccessdata.fda.gov
Stand, InfusionFOX1Specification developeraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Specification developeraccessdata.fda.gov
Stocking, ElasticILG1Specification developeraccessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)DWL2Specification developeraccessdata.fda.gov
Support, Patient PositionCCX1Specification developeraccessdata.fda.gov
Surgeon'S GlovesKGO1Specification developeraccessdata.fda.gov
Syringe, AntistickMEG2Specification developeraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Specification developeraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Specification developeraccessdata.fda.gov
Syringe, PistonFMF2Specification developeraccessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, ManualKST1Specification developeraccessdata.fda.gov
System, Urine Drainage, Closed, For Nonindwelling Catheter, SterileEYZ1Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Specification developeraccessdata.fda.gov
Tourniquet KitOJS1Specification developeraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Specification developeraccessdata.fda.gov
Tourniquet, PneumaticKCY1Specification developeraccessdata.fda.gov
Trap, Sterile SpecimenBYZ2Specification developeraccessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)FCM2Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.fda.gov
TrocarDRC2Specification developeraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Specification developeraccessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or IntubationFEG2Specification developeraccessdata.fda.gov
Tube, LevineFRQ2Specification developeraccessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)BTO2Specification developeraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Specification developeraccessdata.fda.gov
Tubes, Vacuum Sample, With AnticoagulantGIM2Specification developeraccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Specification developeraccessdata.fda.gov
Tubing, Fluid DeliveryFPK2Specification developeraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Specification developeraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Specification developeraccessdata.fda.gov
Urinary Drainage Collection KitPPG2Specification developeraccessdata.fda.gov
Urinary Drainage Collection Kit, For Indwelling CatheterFCN2Specification developeraccessdata.fda.gov
Urinometer, MechanicalEXR2Specification developeraccessdata.fda.gov
Wrap, SterilizationFRG2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 207.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 2, 2026K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZASubstantially EquivalentCardinalhealthaccessdata.fda.gov
April 28, 2026K253243Cardinal Health™ Poly Reinforced Surgical GownFYASubstantially EquivalentCardinal Health 200, LLCaccessdata.fda.gov
January 14, 2026K252313Cardinal Health Nitrile Examination Gloves Extended CuffLZCSubstantially EquivalentCardinalhealthaccessdata.fda.gov
August 22, 2025K243660Monoject™ 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); MonojecFMFSubstantially EquivalentCardinalhealthaccessdata.fda.gov
December 19, 2024K243652Monoject™ 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)PNRSubstantially EquivalentCardinalhealthaccessdata.fda.gov
August 23, 2024K241780Cardinal Health Nitrile Exam GlovesLZASubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
July 27, 2023K230838Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument PocketsFYASubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
July 3, 2023K230569Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )FXXSubstantially EquivalentCardinalhealthaccessdata.fda.gov
June 21, 2023K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)MEGSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
April 3, 2023K230028Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing AssemblyJOWSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
December 20, 2022K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™LZHSubstantially EquivalentCardinal Health, LLCaccessdata.fda.gov
May 19, 2022K213174Salem Sump Silicone Dual Lumen Stomach Tube with ENFit ConnectionPIFSubstantially EquivalentCardinalhealthaccessdata.fda.gov
November 23, 2021K211765Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse GownFYASubstantially EquivalentCardinal Health, LLCaccessdata.fda.gov
September 26, 2021K201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloveKGOSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
June 4, 2021K202217Kendall NPWT Incision Management DeviceOMPSubstantially EquivalentCardinalhealthaccessdata.fda.gov
July 31, 2020K191101Kendall NPWT Incision Management Dressing KitOMPSubstantially EquivalentCardinalhealthaccessdata.fda.gov
July 29, 2020K200824Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical GownFYASubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
March 20, 2020K193327Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage SleeveFYASubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
December 2, 2019K192374Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam StripFXXSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
November 7, 2019K190923Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionPIFSubstantially EquivalentCardinalhealthaccessdata.fda.gov
April 26, 2019K182830Cardinal HealthTM Poly-Coated Open-Back Protective GownQPCSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
December 11, 2018K181174Cardinal Health Sterilization WrapFRGSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
October 23, 2018K180622Kangaroo Gastrostomy Feeding Tube with ENFit Y-PortKNTSubstantially EquivalentCovidienaccessdata.fda.gov
September 22, 2017K171499Occlusion Detection Dressing KitOMPSubstantially EquivalentCardinalhealthaccessdata.fda.gov
June 9, 2017K170762Cardinal Health Non-Reinforced Surgical GownFYASubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
May 16, 2017K163002Kangaroo Feeding Tube with IRIS TechnologyKNTSubstantially EquivalentCovidien (Dba Medtronic)accessdata.fda.gov
January 19, 2017K163620Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression SleevesJOWSubstantially EquivalentCovidienaccessdata.fda.gov
January 19, 2017K161418Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetOMPSubstantially EquivalentCardinalhealthaccessdata.fda.gov
December 23, 2016K163055Reprocessed Kendall SCD Express Foot CuffJOWSubstantially EquivalentCovidienaccessdata.fda.gov
September 1, 2016K161963Monoject Enteral Syringe with ENFit ConnectorPNRSubstantially EquivalentCovidienaccessdata.fda.gov
July 28, 2016K160339Cardinal Health Isolation GownFYCSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
July 11, 2016K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingKGOSubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
July 6, 2016K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect PortalLZHSubstantially EquivalentCovidienaccessdata.fda.gov
May 12, 2016K160419Monoject Enteral Feeding Syringe with ENFit ConnectorPNRSubstantially EquivalentCovidienaccessdata.fda.gov
May 12, 2016K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)KGOSubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
March 24, 2016K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingKGOSubstantially EquivalentCardinal Health 200, Inc.accessdata.fda.gov
October 8, 2015K150711Salem Sump Dual Lumen Stomach Tube with Multi-functional PortPIFSubstantially EquivalentCovidienaccessdata.fda.gov
July 13, 2015K150084Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connectorPIFSubstantially EquivalentCovidienaccessdata.fda.gov
May 29, 2015K143263Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding SetsLZHSubstantially EquivalentCovidienaccessdata.fda.gov
May 21, 2015K150151SmartGownTM surgical gownFYASubstantially EquivalentCardinal Health 200, Inc.accessdata.fda.gov
April 2, 2015K143018Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore ConnectorsPIFSubstantially EquivalentCovidienaccessdata.fda.gov
March 4, 2015K142990Insta-Gard Surgical and Procedure Face MaskFXXSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
March 4, 2015K142916SVED Wound Treatment SystemOMPSubstantially EquivalentCardinalhealthaccessdata.fda.gov
December 23, 2014K141479KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORSLZHSubstantially EquivalentCovidienaccessdata.fda.gov
June 20, 2014K140155SECURE-GARD SURGICAL AND PROCEDURE FACE MASKFXXSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
April 9, 2014K123555KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGYKNTSubstantially EquivalentCovidienaccessdata.fda.gov
November 5, 2013K132567ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMENLJSSubstantially EquivalentCovidienaccessdata.fda.gov
August 27, 2013K132360KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLERJOWSubstantially EquivalentCovidienaccessdata.fda.gov
April 17, 2013K130725MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.FOSSubstantially EquivalentCovidien Lp, Formerly Registered AS Kendallaccessdata.fda.gov
May 11, 2012K112511DOBBHOFF DUAL PORT FEEDING TUBEKNTSubstantially EquivalentCovidien Lp, Formerly Registered AS Kendallaccessdata.fda.gov
April 27, 2012K113707STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATINGKGOSubstantially EquivalentCardinal Health-Medical Products and Servicesaccessdata.fda.gov
September 29, 2011K111878PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVESKGOSubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
September 21, 2011K111868STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATINGKGOSubstantially EquivalentCardinal Health-Medical Products and Servicesaccessdata.fda.gov
June 8, 2011K110272STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGKGOSubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
May 6, 2011K111015STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATINGKGOSubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
April 15, 2011K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZASubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
December 16, 2010K103249NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIMLZASubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
October 15, 2010K101811PROTEGRITY SMT LATEX SURGICALGLOVESKGOSubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
May 4, 2010K100306KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVESJOWSubstantially EquivalentCovidienaccessdata.fda.gov
October 30, 2009K093300ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVESKGOSubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
September 15, 2009K092304ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVESKGOSubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
April 21, 2009K083350TENS/NMES/FES STIMULATING ELECTRODEGXYSubstantially EquivalentCovidien LPaccessdata.fda.gov
February 26, 2009K082296COPA AMDFROSubstantially EquivalentCovidien Lp, Formerly Registered AS Tyco Healthcaraccessdata.fda.gov
February 1, 2008K071866NTRAINER SYSTEMHCCSubstantially EquivalentKcbiomedix, Inc.accessdata.fda.gov
October 16, 2007K071049DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOREZLSubstantially EquivalentTyco Healthcareaccessdata.fda.gov
September 14, 2007K070685KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662FROSubstantially EquivalentTyco Healthcareaccessdata.fda.gov
September 12, 2007K070653KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662FROSubstantially EquivalentTyco Healthcareaccessdata.fda.gov
August 3, 2006K061492MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGEFMFSubstantially EquivalentTyco Healthcareaccessdata.fda.gov
June 5, 2006K061308TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506NFYASubstantially EquivalentCardinal Health 200, Inc.accessdata.fda.gov
May 22, 2006K060649GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000FLLSubstantially EquivalentTyco Healthcare Group LPaccessdata.fda.gov
October 13, 2005K051805KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGEJOWSubstantially EquivalentTyco Healthcare/Kendallaccessdata.fda.gov
January 18, 2005K042709DOVER SILVER TEMPERATURE SENSING FOLEY CATHETEREZLSubstantially EquivalentTyco Healthcareaccessdata.fda.gov
November 5, 2004K042572KENDALL CO2NFIRM NOW CO2 DETECTORKNTSubstantially EquivalentKendallaccessdata.fda.gov
July 20, 2004K040897DOVER ROB-NEL CATHETERKODSubstantially EquivalentTyco Healthcareaccessdata.fda.gov
July 15, 2004K040649KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVEJOWSubstantially EquivalentTyco Healthcareaccessdata.fda.gov
July 7, 2004K041243DOVER RED RUBBER ROBINSON CATHETERKODSubstantially EquivalentTyco Healthcareaccessdata.fda.gov
June 28, 2004K040511SCD EXPRESS PORTABLE COMPRESSION SYSTEMJOWSubstantially EquivalentTyco Healthcare/Kendallaccessdata.fda.gov
May 17, 2004K040388NEXT GENERATION SALEM SUMPFEGSubstantially EquivalentKendallaccessdata.fda.gov
May 5, 2004K040196KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETSLZHSubstantially EquivalentTyco Healthcare/Kendallaccessdata.fda.gov
April 27, 2004K033905PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATINGKGOSubstantially EquivalentCardinalhealthaccessdata.fda.gov
April 9, 2004K040052FINE SURGICAL CIRCUMCISION CLAMPHFXSubstantially EquivalentFine Surgical Instrument Corp.accessdata.fda.gov
November 13, 2003K032444NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPYLZCSubstantially EquivalentCardinalhealthaccessdata.fda.gov
October 15, 2003K031301ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATINGKGOSubstantially EquivalentCardinalhealthaccessdata.fda.gov
June 11, 2003K024010DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETEREZLSubstantially EquivalentThe Kendall Company Div. of Tyco Healthcare Groupaccessdata.fda.gov
October 11, 2002K022765NITRILE POWDER-FREE EXAMINATION GLOVESLZASubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
October 2, 2002K023167BREATHABLE SURGICAL GOWNFYASubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
March 18, 2002K020593CONVERTORS SMS POLYOLEFIN GOWNFYASubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
October 25, 2001K012736MONOJECT SAFETY NEEDLEFMISubstantially EquivalentTyco Healthcareaccessdata.fda.gov
October 12, 2001K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESDROSubstantially EquivalentThe Ludlow Company LPaccessdata.fda.gov
August 22, 2001K011941EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088FROSubstantially EquivalentThe Kendall Companyaccessdata.fda.gov
August 14, 2001K011721ESTEEM STERILE POLYISOPRENE SURGICAL GLOVESKGOSubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
February 15, 2001K010211STERILE NITRILE POWDER-FREE EXAMINATION GLOVESLZCSubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
January 11, 2001K003313FILAC FAS TEMP ELECTRONIC THERMOMETERFLLSubstantially EquivalentThe Kendall Companyaccessdata.fda.gov
July 14, 2000K001924COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0KGOSubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
January 31, 2000K990530KERLIX MD ANTIMICROBIAL GAUZE DRESSINGNADSubstantially EquivalentThe Kendall Company, L.P.accessdata.fda.gov
September 28, 1999K990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946CEZLSubstantially EquivalentThe Kendal Co.accessdata.fda.gov
September 17, 1999K983097TENS/FES/NMES ELECTRODESGXYSubstantially EquivalentUni-Patch, Inc.accessdata.fda.gov
September 14, 1999K992171COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGOSubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
June 14, 1999K991758MONOJECT INSULIN SYRINGEFMFSubstantially EquivalentThe Kendal Co.accessdata.fda.gov
December 10, 1998K983187MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLEKNWSubstantially EquivalentMedsol Corp.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
August 7, 2020P190007Cardinal Health Multifunctional Defibrillation ElectrodeMKJ0August 7, 2020accessdata.fda.gov

Compare with other makers

Updated September 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.