7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REAGIN ANTIGEN SUSPENSION
FDA 510(k)
FDA Class 2
·Microbiology
VERTIFLEX DIRECT DECOMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DIATEK CANNON-CATHETER, MODEL CC5500
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014
ETRIO
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·November 7, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code NQP·August 27, 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