11 results
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22ms
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Sources: EU EUDAMED, US FDA
BlueStar CGM insulin dose calculator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ACUBEAM, SUPER NOVA, DIO
FDA 510(k)
FDA Class 2
·Physical Medicine
4.75 HEALIX ADVANCE KNTLS PEEK
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·May 24, 2021
FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE
FDA Adverse Event
Malfunction
·ASSET MEDIKAL TASARIM SAN. TIC. A.S.·Product code FPA·July 24, 2025
G7 FREEDOM CONSTRAINED E1 LINER 36MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·April 27, 2018
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
MARYLAND BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·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