8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LUQUE SEGMENTAL SPINAL INSTRUMENTATION
FDA 510(k)
FDA Class 2
·Orthopedic
TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
FDA 510(k)
FDA Class 2
·Orthopedic
LIGHTSPEED 4.0 CT SCANNER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ONYX AVM
FDA Adverse Event
Death
·EV3 NEUROVASCULAR·Product code MFE·March 31, 2011
OPTI Q SVO2/CCO CATHETER
FDA Adverse Event
Injury
·HOSPIRA, INC.·Product code DQE·November 30, 2010
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NIK·July 3, 2014
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 21, 2012
PKG, BIPOLAR FORCEPS, FENESTRATED, 45CM, P/N 0250080350. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014