8 results
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18ms
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Sources: EU EUDAMED, US FDA
COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788223860·Cervical Rasp + DS 7x16x13 Flat
VICTUS FEMTOSECOND LASER PLATFORM
FDA 510(k)
FDA Class 2
·Ophthalmic
POCKETCHEM UA AUTION STICKS 10TA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2014
LIGAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code JDQ·June 13, 2012
HS HAND CONTROLLED CURVED SHEA
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GEI·August 17, 2007
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