Data / Medical devices / United States / Cardinal Health
Cardinal Health: FDA-registered device maker in Chicopee, MA, United States, 6 510(k) clearances and 1 PMA approval
Cardinal Health is registered with the FDA (registration 1219103) in Chicopee, MA, United States. It lists 12 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated August 7, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1219103
- FEI number
- 1000148701
- Address
- 2 Ludlow Park Dr, Chicopee, MA, United States, 01022
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- August 4, 1999
- Registered through
- 2026
Devices it lists
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 |
|---|---|---|---|---|---|---|
| October 12, 2001 | K012218 | LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES | DRO | Substantially Equivalent | The Ludlow Company LP | accessdata.fda.gov |
| December 15, 1997 | K973507 | KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) | FRO | Substantially Equivalent for Some Indications | Kendall Healthcare Products Co. Div.Of Tyco Health | accessdata.fda.gov |
| August 23, 1995 | K952945 | AQUAFLO HYDROGEL WOUND DRESSING & PACKER | NAE | Substantially Equivalent for Some Indications | Sherwood Medical Co. | accessdata.fda.gov |
| July 26, 1994 | K943073 | CURAFIL WOUND GEL DRESSING | MGQ | Substantially Equivalent for Some Indications | Kendall Healthcare Products Co. Div.Of Tyco Health | accessdata.fda.gov |
| January 29, 1991 | K904745 | MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE | HGP | Substantially Equivalent | Graphic Controls Corp. | accessdata.fda.gov |
| September 16, 1981 | K812527 | IVA SEAL II | KPE | Substantially Equivalent | U.S. Clinical Products, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 7, 2020 | P190007 | Cardinal Health Multifunctional Defibrillation Electrode | MKJ | 0 | August 7, 2020 | accessdata.fda.gov |
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Updated August 7, 2020. 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.