8 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
FDA 510(k)
FDA Class 2
·Hematology
AXSOS
FDA UDI
Stryker GmbH·07613327087802·Tag Distal Medial Tibia
ANTHRACIS REAL-TIME PCR ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
TRANS1 AXIAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNICEL® DXC 600 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·February 3, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·December 20, 2010
SP2 TIBIAL RADEL IMPACTOR
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·July 17, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020