23 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SMARTLOC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Flexitron
FDA UDI
Nucletron B.V.·08717213022393·Flexitron Transfer Tube Set for 4F Flexibles (3...
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
6F ENGAGE/ENGAGE TR INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
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
UNKNOWN BEACON NEEDLE
FDA Adverse Event
Injury
·COVIDIEN LP BARRX·Product code FCG·March 29, 2022
8CM HEAVY DUTY MEDIUM ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·May 7, 2013
AXSYM CMV IGG REAGENT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFZ·June 2, 2011
POLARCATH
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQY·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
Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
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