7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DELFIA SHBG KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
FDA 510(k)
FDA Class 2
·Immunology
10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·February 4, 2013
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 17, 2010
ENDEAVOR SPRINT RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·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