7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM
FDA 510(k)
FDA Class 1
·Radiology
AERO BLUE PERFORMANCE SURGICAL GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELLIPTIC MATRIX
FDA 510(k)
FDA Class 2
·Dental
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 18, 2014
AEQUALIS GLENOID RESURFACING HEAD
FDA Adverse Event
Injury
·TORNIER INC.·Product code KWY·January 30, 2013
UNKNOWN ZIMMER ZMR HIP STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWY·December 21, 2010
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