8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SCISSORS: THOREK, JORGENSEN, FINOCHIETTO
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MODEL SE-1 EYEGLASS HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
CORTISOL RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CURRENT ACCEL VR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 29, 2010
TRAUMA DRILL
FDA Adverse Event
Other
·ZIMMER GMBH·Product code HWE·December 11, 2012
BD VACUTAINER® GLUCOSE GLASS TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 27, 2018
TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 19, 2013