Data / Medical devices / United States / Cardinal Health
Cardinal Health: FDA-registered device maker in Deland, FL, United States, 9 510(k) clearances
Cardinal Health is registered with the FDA (registration 1017768) in Deland, FL, United States. It lists 10 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1017768
- Address
- 2010 E International Speedway Blvd, Deland, FL, United States, 32724
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 23, 1977
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Manufacturer | accessdata.fda.gov |
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 22, 2025 | K243660 | Monoject 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); Monojec | FMF | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| December 19, 2024 | K243652 | Monoject 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) | PNR | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| September 1, 2016 | K161963 | Monoject Enteral Syringe with ENFit Connector | PNR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 25, 2001 | K012736 | MONOJECT SAFETY NEEDLE | FMI | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| February 26, 1997 | K963351 | LIFESHIELD BLUNT CANNULA | FMI | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| December 23, 1996 | K960982 | MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA | FMI | Substantially Equivalent | Sherwood Medical Co. | 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 |
| February 4, 1986 | K854547 | MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE | FMI | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| July 23, 1985 | K852544 | MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES | FMF | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Enteral Syringes With Enteral Specific Connectors
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Syringe, Piston
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Periodontic, Endodontic, Irrigating
- All makers of Container, Liquid Medication, Graduated
Updated August 22, 2025. 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.