Cardinal Health200, LLC FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Cardinal Health Nitrile Exam Gloves510(k)Aug 23, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Aug 23, 2024
Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets510(k)Jul 27, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 27, 2023
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)510(k)Jun 21, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Jun 21, 2023
Kendall 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 Assembly510(k)Apr 3, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 3, 2023
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove510(k)Sep 26, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 26, 2021
Nitrile Blue Powder-free Examination Glove510(k)Aug 28, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 28, 2021