Data / Medical devices / Japan / Cardinal Health K.K.
Cardinal Health K.K.: FDA-registered device maker in FUKUROI Shizuoka, Japan, 16 510(k) clearances
Cardinal Health K.K. is registered with the FDA (registration 3012341425) in FUKUROI Shizuoka, Japan. It lists 10 device types. The FDA files 16 510(k) clearances under its listings, the newest dated July 11, 2016. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012341425
- Address
- 3033 Moroi, FUKUROI Shizuoka, Japan, 437-1121
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Exporter to the US
- First device listed
- December 31, 1977
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Exporter to the US | accessdata.fda.gov |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Exporter to the US | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Exporter to the US | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Exporter to the US | accessdata.fda.gov |
| Pump, Infusion, Enteral | LZH | 2 | Exporter to the US | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Exporter to the US | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Exporter to the US | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Exporter to the US | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 11, 2016 | K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| May 12, 2016 | K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| March 24, 2016 | K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | KGO | Substantially Equivalent | Cardinal Health 200, Inc. | accessdata.fda.gov |
| April 27, 2012 | K113707 | STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING | KGO | Substantially Equivalent | Cardinal Health-Medical Products and Services | accessdata.fda.gov |
| September 29, 2011 | K111878 | PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| September 21, 2011 | K111868 | STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING | KGO | Substantially Equivalent | Cardinal Health-Medical Products and Services | accessdata.fda.gov |
| June 8, 2011 | K110272 | STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| May 6, 2011 | K111015 | STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| October 15, 2010 | K101811 | PROTEGRITY SMT LATEX SURGICALGLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| May 4, 2010 | K100306 | KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES | JOW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 30, 2009 | K093300 | ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| September 15, 2009 | K092304 | ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| June 28, 2004 | K040511 | SCD EXPRESS PORTABLE COMPRESSION SYSTEM | JOW | Substantially Equivalent | Tyco Healthcare/Kendall | accessdata.fda.gov |
| May 5, 2004 | K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | LZH | Substantially Equivalent | Tyco Healthcare/Kendall | accessdata.fda.gov |
| July 14, 2000 | K001924 | COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0 | KGO | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| March 1, 1995 | K945715 | MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES | FMF | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Sleeve, Limb, Compressible
- All makers of Surgeon'S Gloves
- All makers of Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- All makers of Accessories, Catheter
- All makers of Syringe, Piston
- All makers of Bandage, Cast
Updated July 11, 2016. 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.