12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tyber Medical Trauma Screw
FDA 510(k)
FDA Class 2
·Orthopedic
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
FDA 510(k)
FDA Class 2
·Cardiovascular
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·October 22, 2014
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 27, 2013
UNKNOWN
FDA Adverse Event
Death
·UNKNOWN·Product code LTI·March 6, 2008
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025