14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPEEDY FLAP SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925018785·MCGEE STRAIGHT PICK
AT HOME DRUG CUP, MODEL 9150X
FDA 510(k)
FDA Unclassified
·Unknown
MYOSCIENCE CRYO-TOUCH
FDA 510(k)
FDA Class 2
·Neurology
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code ILS·May 24, 2013
DA+ C SERIES DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·August 19, 2008
BD VIPER¿ LT SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code OOI·August 14, 2023
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·October 30, 2017
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 9, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·February 28, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 8, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·April 25, 2018
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024