43 results · 29ms · Sources: EU EUDAMED, US FDA

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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