8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
TOURNIQUET PRESSURE REGULATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MODIFICATION TO: UNITY NETWORK ID
FDA 510(k)
FDA Class 2
·Cardiovascular
DROPLET PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 12, 2021
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 13, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALER SAN DIEGO, INC.·Product code GJS·December 11, 2012
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 26, 2015
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024