8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
VYGON EPIDURAL ANAESTHESIA TRAY
FDA 510(k)
FDA Class 2
·Anesthesiology
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788226910·Cervical Rasp, Thin Shaft, 6x14x12, 6 deg
OCCUPAK CAT.#200-0538
FDA 510(k)SILICONE IMPLANTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PARADYM
FDA Adverse Event
Injury
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code NIK·May 21, 2014
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 7, 2012
PFC SIGMARP CV TB/IN S3 10.0
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·August 27, 2010
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012