19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CLOSUREFAST RADIOFREQUENCY CATHETER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexitron
FDA UDI
Nucletron B.V.·08717213027268·Flexitron Transfer Tube for 4F Flexibles (34)
AVALON CUP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CONFIDENT SURGERY SUITE 300, MODEL CSS300
FDA 510(k)
FDA Class 1
·Radiology
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 21, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 21, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMP,TSV,MCOL MG,3.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 23, 2024
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 1, 2023
11.0 CM LONG ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·May 14, 2013
EBICE MODEL 10D
FDA Adverse Event
Injury
·EBI, LLC·Product code ILO·June 2, 2011
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR GALWAY·Product code NIM·August 12, 2008
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·June 16, 2022
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 9, 2025
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 27, 2024
IMP,TSV,MCOL MG,4.7MM,13M
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 20, 2023
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code DZE·February 13, 2019
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
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020