8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
W&H 798 TOP AIR TURBINE TRIPLE SPRAY
FDA 510(k)
FDA Class 1
·Dental
MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT
FDA 510(k)
FDA Class 2
·Ophthalmic
MICRO-VENT NEBULIZER SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
FRESENIUS DIALYSIS DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE-NORTH AMERICA·Product code KDI·May 16, 2008
INSYNC III
FDA Adverse Event
Death
·IPG MFG SWITZERLAND·Product code LWP·February 5, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 3, 2011
TMAX
FDA Adverse Event
Injury
·OKLAHOMA CITY MANUFACTURING SITE·Product code FWZ·July 18, 2014
PKG, 3MM INSERT, DORSEY GRASPER, 29CM, P/N 0250282097 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