88 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K-PACK II NEEDLE- 27G & 30G THIN WALL
FDA 510(k)
FDA Class 2
·General Hospital
JOBST SensiFoot
FDA UDI
BSN MEDICAL, INC.·00035664108502·SENSIFOOT 8-15 MM HG CREW EXTRA SMALL BLACK 1 E...
Prima Titanium Implant 5.0mmd/8mml
FDA UDI
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD·07290112760029·"PRTI - is a self-tapping titanium dental impla...
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1103500·Tray, Base, 3.5", Arcamed
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100500·Caddie, 4.75mm Screws
POLESTAR N-10
FDA 510(k)
FDA Class 2
·Radiology
COWELL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·July 13, 2022
BIOMET BONE CEMENT R 40X2
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·November 9, 2016
BIOMET BONE CEMENT V
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·December 1, 2016
BIOMET BONE CEMENT V
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·December 1, 2016
OPTIPAC-S 60 REFOBACIN BONE CEMENT R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·June 14, 2016
REFOBACIN BONE CEMENT R 2X40G
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·February 2, 2018
OPTIPAC-S KNEE REFOBACIN PLUS BONE CEMNT
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·May 25, 2016
BIOMET BONE CEMENT 1X40G
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·July 22, 2016
BIOMET BONE CEMENT R 2X40G
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·July 9, 2016
OPTIPAC-S 60 REFOBACIN BONE CEMENT R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·May 23, 2016
OPTIPAC-S 40 REFOBACIN PLUS BONE CEMENT
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·May 25, 2016
OPTIPAC-S 40 REFOBACIN PLUS BONE CEMENT
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·May 25, 2016
BIOMET BONE CEMENT V
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·December 1, 2016