12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Envision 3D: Image Guidance System
FDA 510(k)
FDA Class 2
·Neurology
BI-METRIC HIP SYSTEM
FDA UDI
Biomet Uk Ltd·00880304252356·
LUCIA
FDA 510(k)
FDA Class 2
·Physical Medicine
MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
GENISTRONG
FDA Adverse Event
Malfunction
·GENICON·Product code GCJ·October 15, 2017
NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 2, 2012
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 10, 2014
VERSA DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·September 9, 2008
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
FDA Enforcement
Class II
·Terminated·Smith & Nephew Inc·March 20, 2013
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDS·February 7, 2013