43 results
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29ms
·
Sources: EU EUDAMED, US FDA
MYOCENE
FDA registration
MYOCENE·2 products·🇧🇪 Belgium
Myocene
FDA UDI
Myocene·05430004268000·The Myocene device is intended to provide objec...
Myocene Electrode
FDA UDI
Myocene·05430004268017·An electrical conductor intended to be attached...
Myocene
FDA 510(k)
FDA Class 2
·Neurology
MYOMEN INSTRUMENT
FDA Adverse Event
Malfunction
·KARL STORZ SE & CO. KG·Product code HET·September 2, 2025
SMILE DIRECT CLUB INVISIBLE ALIGNERS
FDA Adverse Event
Injury
·SMILEDIRECTCLUB / ALIGN TECHNOLOGY, INC.·Product code NXC·October 23, 2019
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2015
AMBU
FDA Adverse Event
Injury
·AMBU·Product code IKT·November 5, 2012
BLOOD GLOUSE MONITOR
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code QBJ·December 9, 2025
BLOOD GLOUSE MONITOR
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC.·Product code QBJ·December 9, 2025
BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 6, 2019
BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 1, 2022
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 10, 2013
BYTE NIGHT ALIGNERS
FDA Adverse Event
Injury
·STRAIGHT SMILE, LLC·Product code NXC·January 20, 2025
Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016
FDA Recall
Terminated
·Intelligent Hearing Systems Corp.·Product code GWJ·October 21, 2008
CAPSURE Z NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 9, 2013
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 9, 2013
SAUNDERS CERVICAL TRACTION
FDA Adverse Event
Injury
·CHATTANOOGA GROUP·Product code IRS·August 10, 2010
NTI
FDA Adverse Event
Injury
·NDX NATIONAL DENTEX LABS·Product code OCO·January 12, 2021
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013