9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VICTUS FEMTOSECOND LASER PLATFORM
FDA 510(k)
FDA Class 2
·Ophthalmic
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
POCKETCHEM UA AUTION STICKS 10TA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 28, 2020
TARGET DEVICE 300X160MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 2, 2012
11.25CM ATTACHMENT, BLACK MAX
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GFF·May 21, 2013
MACH1 GUIDE CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·September 26, 2014
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·June 13, 2011
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012