8 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SECURE Screw
FDA 510(k)
FDA Class 2
·Orthopedic
NON-CONTACT TEAR FILM THERMOGRAGH
FDA 510(k)
FDA Class 2
·Ophthalmic
RELINE-IT MODEL RELINE-IT
FDA 510(k)
FDA Class 2
·Dental
PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MBH·August 29, 2016
QUARTET
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC. CRMD·Product code DTB·January 13, 2014
AUTOPULSE? RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC·Product code DRM·June 26, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 28, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018