Kelyniam Global, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Kelyniam Global, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Fusion Craniofacial Implant, Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
4
Total
4
Cleared
0
Denied
Kelyniam Global, Inc. has 4 FDA 510(k) cleared medical devices. Based in New Britain, US.
Latest FDA clearance: Jul 2025. Active since 2011. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Kelyniam Global, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Kelyniam Global, Inc.
4 devices
Cleared
Jul 25, 2025
Fusion Craniofacial Implant
Neurology
170d
Cleared
May 21, 2019
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
Neurology
236d
Cleared
Sep 25, 2012
CUSTOM CRANIOFACIAL IMPLANT (CCI)
Neurology
102d
Cleared
Apr 14, 2011
KELYNIAM CUSTOM SKULL IMPLANT (CSI)
Neurology
127d