7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
TRACOR RA500 AUDIOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VICRYL Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNGO TRUED
FDA 510(k)
FDA Class 2
·Radiology
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code HDD·November 2, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 31, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 29, 2012
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012