15 results
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36ms
·
Sources: EU EUDAMED, US FDA
FILAFEX ESTHETIC ORTHODINIC WIRE
FDA 510(k)
FDA Class 1
·Dental
COOK HOLMIUM LASER FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 27, 2014
12X60MM KII OPITCAL ACCESS SYSTEM THREADED 6/BOX
FDA Adverse Event
APPLIED MEDICAL·Product code GCJ·November 5, 2012
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·September 9, 2010
COOK® MULTI-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·May 10, 2019
COOK SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 21, 2020
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·August 19, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·October 15, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·December 10, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·November 4, 2022
COOK SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 3, 2020
COOK SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 13, 2020
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018