7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
EMERGENCY TRACHEOSTOMY KIT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HANDHELD ECG MONITOR, MODEL MD100
FDA 510(k)
FDA Class 2
·Cardiovascular
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
M2A 38MMX56MM CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 25, 2014
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·January 2, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 1, 2010