12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IlluminOss Bone Stabilization System
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE
FDA Adverse Event
Malfunction
·ASSET MEDIKAL TASARIM SAN. TIC. A.S.·Product code FPA·July 24, 2025
TEMA ELBOW SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code JDB·September 26, 2024
RESOLUTION CLIP DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MND·November 6, 2008
SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE
FDA Adverse Event
Other
·GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·August 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·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
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025