9 results
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20ms
·
Sources: EU EUDAMED, US FDA
ORTHO TECH CRYOLOGIC SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
XLIF
FDA UDI
Nuvasive, Inc.·00887517452764·XLIF Pituitary, Small
AXSOS
FDA UDI
Stryker GmbH·07613327087789·Tag Distal Lateral Femur
CRANE ACRYLIC HERBST APPLIANCE
FDA 510(k)
FDA Class 2
·Dental
Trilogy Tissue Marker
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 17, 2010
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code NPT·February 4, 2013
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