FDA 510(k) Applications Submitted by Halyard Health

FDA 510(k) Number Submission Date Device Name Applicant
K150113 01/20/2015 Fusion Black Powder-Free Nitrile Exam Glove Halyard Health
K153708 12/23/2015 Halyard Black-Orange Powder-Free Nitrile Exam Glove Halyard Health
K180646 03/12/2018 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Halyard Health
K160709 03/14/2016 HALYARD* PURPLE NITRILE û XTRA* Powder-Free Exam Gloves Halyard Health
K161232 05/02/2016 ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit HALYARD HEALTH
K181360 05/22/2018 ON-Q* Pump with Bolus Halyard Health
K141712 06/25/2014 KIMGUARD ONE STEP STERILIZATION WRAP Halyard Health


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact