7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
FDA 510(k)
FDA Class 2
·Dental
HOME-AWAY SYSTEM, MODEL 1041
FDA 510(k)
FDA Class 2
·Anesthesiology
ArthroPlan Digital Templating Software
FDA 510(k)
FDA Class 2
·Radiology
SIGNA EXCITE 3.0T
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code LNH·November 21, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
UNKNOWN PELVICOL PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES·Product code FTL·July 12, 2013
PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 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