9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONDYLAFORM II NFC
FDA 510(k)
FDA Class 2
·Dental
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70605651·Mini-Mono-Brackets Roth 'N' .022" 1000 Brackets...
DYNATRON STS
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO NC-STAT
FDA 510(k)
FDA Class 2
·Neurology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·March 27, 2013
LANCET
FDA Adverse Event
Malfunction
·LIBERTY MEDICAL·Product code FMK·June 17, 2008
MODULAR CATHCART BALL 54MM OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LZY·April 6, 2011
UNKNOWN BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 10, 2017
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016