7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DUAL PURPOSE CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
PW DOPPLER VASCULAR PROBES
FDA 510(k)
FDA Class 2
·Radiology
RSTAR IMAGE MANAGMENT SYTEM (RSTAR-IMS)
FDA 510(k)
FDA Class 1
·Radiology
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FNL·January 7, 2013
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·December 28, 2010
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·July 21, 2014
PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 29CM, P/N 0250282061 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