9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
X-MARX
FDA 510(k)
FDA Class 1
·Radiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450211021·
PSX Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNI LFIT MEDIAL FEMORAL COMP.
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code HRY·April 15, 2013
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·June 8, 2016
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 13, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
UNKNOWN BLADE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS CORK·Product code HAB·November 23, 2010