8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR
FDA 510(k)
FDA Class 1
·General Hospital
Powered Wheelchair
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CESAR OMCP VISUB CCD V5000
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code IZI·December 3, 2010
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·February 4, 2013
LANCET DEVICE SNSRTR CMFRT EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·July 17, 2014
PKG, 3MM INSERT, FUNDUS GRASPER, 20CM, P/N 0250282003 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
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015