7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
URETHRO CATHETERIZATION TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 30, 2014
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·October 10, 2012
SWIFT LT FOR HER MASK SYSTEM - USA
FDA Adverse Event
Injury
·RESMED LTD.·Product code BZD·July 30, 2010
9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017