Phenox Limited is one of 55 FDA 510(k) medical device manufacturers from Ireland in the dataset, ranked by real submission volume.
Phenox Limited - FDA 510(k) Cleared Devices
Recent clearances: pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device, pRESET LITE Thrombectomy Device, pRESET Thrombectomy Device
4
Total
4
Cleared
0
Denied
Phenox Limited has 4 FDA 510(k) cleared medical devices. Based in Galway, IE.
Latest FDA clearance: Feb 2025. Active since 2019. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Phenox Limited Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Phenox Limited
4 devices
Cleared
Feb 28, 2025
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
Neurology
175d
Cleared
Oct 21, 2023
pRESET LITE Thrombectomy Device
Neurology
144d
Cleared
CT
Jan 20, 2023
pRESET Thrombectomy Device
Neurology
121d
Cleared
Oct 09, 2019
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
Neurology
107d