18 results
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25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
FDA 510(k)
FDA Class 3
·Cardiovascular
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311315250·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321315250·
PERIMETER INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
PIONEER SPINOUS PROCESS FUSION PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ENVISTA INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·March 23, 2015
ENVISTA INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·March 23, 2015
ENVISTA INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·March 23, 2015
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 5, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 6, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 5, 2019
STEALTHSTATION® S7´
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 20, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 17, 2019
PARADYM
FDA Adverse Event
Injury
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code MRM·October 1, 2014
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 14, 2013
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 16, 2011
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 7, 2025