8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
IMX FOLLICLE STIMULATING HORMONE (FSH)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GYRUS ACMI
FDA UDI
Gyrus ACMI, LLC·00821925022003·MUD (MULTI-USE DISPOSABLE) LARGE STERILIZING CA...
TRIMIRA IDENTAFI 3000
FDA 510(k)
FDA Class 2
·Dental
MONITOR, PRESSURVEIL
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUANOX MODEL 7600 REGIONAL OXIMETRY SYSTEM
FDA Adverse Event
NONIN MEDICAL INC·Product code DQA·May 29, 2014
ATLAS PLUS DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·December 28, 2012
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 29, 2010
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