7 results
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25ms
·
Sources: EU EUDAMED, US FDA
NIDEK AR-1200
FDA 510(k)
FDA Class 1
·Ophthalmic
FOOTPRINT MEDICAL SILICONE FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
FDA 510(k)
FDA Class 2
·General Hospital
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 24, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP. MEDICAL DIV.·Product code FNL·October 29, 2010
COLLAMED FM
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTM·December 12, 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