8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
ACTIVE CROSSLAPS ELISA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HA Bone Screws
FDA UDI
ORTHOFIX SRL·18032568862003·OSTEOTITE SELF-DRILL.220/30 MM BONE SCREW THREA...
Illuminated Mediastinal Access Port
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CLEANSE S+ ULTRASONIC SCALER
FDA 510(k)
FDA Class 2
·Dental
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code NMJ·June 24, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 14, 2013
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·December 15, 2010
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015