7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MAKLAKOV STYLE TONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
SEE-IT CARIES DETECTOR
FDA 510(k)
FDA Class 2
·Dental
CANNULA, DISPOSABLE OXYGEN TTHERAPY
FDA 510(k)
FDA Class 1
·Anesthesiology
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code NVY·June 10, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·December 6, 2012
HUDSON NEONATAL VENTILATOR CIRCUIT, HEATED-WIRE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·September 24, 2010
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012