9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FlowStar Touch Digital Mixer Flowmeter
FDA 510(k)
FDA Class 2
·Anesthesiology
TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 7, 2012
E-SPEED EBT SCANNER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
UPSYLON Y MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SAF-T HOLDER
FDA Adverse Event
Malfunction
·SMITHS MEDICAL·Product code JKA·August 16, 2011
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. SHANGHAI·Product code INI·November 4, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025