7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
JESBERG ESOPHAGOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AMIKACIN CONTROL SERUM
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Philips IntelliSite Pathology Solution
FDA 510(k)
FDA Class 2
·Pathology
FOUNDATION KNEE
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code JWH·June 24, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 2, 2010
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 27, 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