7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DUAL LUMEN CATHETER (DLC) TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Versus Catheter (VS110-8B)
FDA 510(k)
FDA Class 2
·Cardiovascular
NAVILAS LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRIDENT ALUMINA INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MRA·February 4, 2013
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC·Product code GJS·December 22, 2010
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 17, 2014
PKG, BABCOCK FORCEPS, PADDLE, P/N 0250080250. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014