Data / Medical devices / United States / Cardinal Health
Cardinal Health: FDA-registered device maker in Norfolk, NE, United States, 23 510(k) clearances
Cardinal Health is registered with the FDA (registration 1915484) in Norfolk, NE, United States. It lists 13 device types. The FDA files 23 510(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
- 1915484
- Address
- 1222 Sherwood RD., Norfolk, NE, United States, 68701
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- February 2, 1994
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Device, Specimen Collection | LIO | 1 | Contract manufacturer | accessdata.fda.gov |
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Manufacturer | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Contract sterilizer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vacuum Sample, With Anticoagulant | GIM | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Contract manufacturer, 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 |
| June 21, 2023 | K223376 | Monoject 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) | MEG | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| September 1, 2016 | K161963 | Monoject Enteral Syringe with ENFit Connector | PNR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 3, 2006 | K061492 | MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE | FMF | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| May 22, 2006 | K060649 | GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 | FLL | Substantially Equivalent | Tyco Healthcare Group LP | accessdata.fda.gov |
| October 25, 2001 | K012736 | MONOJECT SAFETY NEEDLE | FMI | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| January 11, 2001 | K003313 | FILAC FAS TEMP ELECTRONIC THERMOMETER | FLL | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
| June 14, 1999 | K991758 | MONOJECT INSULIN SYRINGE | FMF | Substantially Equivalent | The Kendal Co. | 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 |
| December 17, 1992 | K920713 | FIRSTTEMP GENIUS | FLL | Substantially Equivalent | Intelligent Medical Systems | accessdata.fda.gov |
| November 25, 1992 | K922522 | MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES | FMF | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| January 8, 1992 | K915213 | CORVAC BLOOD COLLECTION TUBE | GIM | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| September 27, 1988 | K883320 | MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE | JKA | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| August 6, 1987 | K860688 | MONOJECT PHARMACY TRAY | FMF | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| July 23, 1985 | K852588 | MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES | FMF | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| April 12, 1985 | K851090 | MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE | FMF | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| June 29, 1977 | K771056 | BLOOD COLLECTION TUBE, GREEN | GIM | Substantially Equivalent | Sherwood Medical Industries | accessdata.fda.gov |
| June 29, 1977 | K771055 | BLOOD COLLECTION TUBE, RED | GIM | Substantially Equivalent | Sherwood Medical Industries | accessdata.fda.gov |
| June 29, 1977 | K771054 | BLOOD COLLECTION TUBE, BLUE | GIM | Substantially Equivalent | Sherwood Medical Industries | accessdata.fda.gov |
| June 29, 1977 | K771053 | BLOOD COLLECTION TUBE, GRAY | GIM | Substantially Equivalent | Sherwood Medical Industries | accessdata.fda.gov |
| June 27, 1977 | K771052 | BLOOD COLLECTION TUBE, LAVENDER | GIM | Substantially Equivalent | Sherwood Medical Industries | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Vacuum Sample, With Anticoagulant
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Clinical Electronic Thermometer
- All makers of Syringe, Piston
- All makers of Enteral Syringes With Enteral Specific Connectors
- All makers of Continuous Measurement Thermometer
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.