14 results
·
24ms
·
Sources: EU EUDAMED, US FDA
LenSX Laser System
FDA 510(k)
FDA Class 2
·Ophthalmic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517566898·CoRoent Ant TLIF PEEK, 16x11x28mm 8°
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STAXX XD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 13, 2011
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·September 15, 2008
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·March 23, 2018
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