24 results
·
22ms
·
Sources: EU EUDAMED, US FDA
iVitri EZ
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741626400·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674162640060·
Distal Centralizer/Centering Sleeve
FDA UDI
Biomet Orthopedics, LLC·00887868542381·
Answer® / Impact® / Integral® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868273223·
ANSWER / IMPACT / INTEGRAL HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304253087·
Zavation
FDA UDI
Zavation LLC·00842166149502·16x26x40mm, 0°, MILC
Zavation
FDA UDI
Zavation LLC·00842166150256·16x26x40mm, 6°, MILC
Zavation
FDA UDI
Zavation LLC·00842166153912·16x26X40mm, 12°, MILC
VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS
FDA 510(k)
FDA Class 2
·Dental
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 14, 2017
PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 8, 2017
PALACOS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LOD·February 16, 2018
PALACOS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LOD·February 16, 2018
EVERA XT DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014
COBAS E411 RACK SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code DHA·June 11, 2013
ORBERA INTRAGASTRIC BALLOON
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code LTI·October 20, 2015
PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·October 10, 2017