7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH
FDA 510(k)
FDA Class 3
·Cardiovascular
YO Home Sperm Test
FDA 510(k)
FDA Class 2
·Hematology
APEX PINS
FDA 510(k)
FDA Class 2
·Orthopedic
PROTECTA XT DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·June 10, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 28, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012