Isikel Manufacturing, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Isikel Manufacturing, LLC - FDA 510(k) Cleared Devices
Recent clearances: Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
1
Total
1
Cleared
0
Denied
Isikel Manufacturing, LLC has 1 FDA 510(k) cleared medical devices. Based in Katy, US.
Last cleared in 2023. Active since 2023. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Isikel Manufacturing, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Smith Associates as regulatory consultant.
FDA 510(k) Regulatory Record - Isikel Manufacturing, LLC
1 devices