10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Titan Modular Shoulder System 2.5
FDA UDI
Smith & Nephew, Inc.·00885556862193·BODY SEPARATOR
CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)
FDA 510(k)
FDA Class 2
·Orthopedic
SONOREAL 3D SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Titan™
FDA UDI
Ascension Orthopedics, Inc.·10381780247425·Titan™ Total Shoulder System
The body separator...
BODY SEPARATOR
FDA Adverse Event
Malfunction
·ASCENSION ORTHOPEDICS·Product code HXW·October 8, 2020
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·December 10, 2010
EPIC ILIAC¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIO·January 17, 2013
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 8, 2014
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020