7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LINGRAPHICA VISUAL LANGUAGE PROSTHESIS
FDA 510(k)
FDA Class 2
·Physical Medicine
HUBUKA HYG TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·February 6, 2013
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·January 4, 2011
SEE H10
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·July 21, 2014
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. 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