Halyard Health, Inc. is one of 16037 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Halyard Health, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Mic-Key* SF Over-the-Wire Stoma Measuring Device, Aero Chrome* Select Breathable Performance Surgical Gowns, Coolief* Cooled RF Probe
7
Total
6
Cleared
0
Denied
Halyard Health, Inc. has 6 FDA 510(k) cleared medical devices. Based in Roswell, US.
Historical record: 6 cleared submissions from 2015 to 2018. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Halyard Health, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Third Party Review Group, LLC as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Halyard Health, Inc.
7 devices
Cleared
Jan 26, 2018
Mic-Key* SF Over-the-Wire Stoma Measuring Device
Gastroenterology & Urology
29d
Cleared
Apr 21, 2017
Aero Chrome* Select Breathable Performance Surgical Gowns
General Hospital
184d
Cleared
CT
Apr 13, 2017
Coolief* Cooled RF Probe
Neurology
125d
Cleared
Dec 16, 2016
COOLIEF Cooled Radiofrequency Kit
Neurology
29d
Cleared
Apr 13, 2016
Aero Chrome* Breathable Performance Surgical Gown
General Hospital
155d
Cleared
Mar 24, 2015
MiniStim MS-IVB Peripheral Nerve Stimulator
Anesthesiology
147d
Cleared
Mar 24, 2015
Fluidshield* Surgical Mask with Expanded Chamber
General Hospital
127d