231 results
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32ms
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Sources: EU EUDAMED, US FDA
SMARTLIPO ND: YAG LASER SYSTEM
FDA Adverse Event
Injury
·CYNOSURE INC.·Product code GEX·August 2, 2017
ICON
FDA Adverse Event
Injury
·Product code GEX·July 29, 2014
ELITE MD
FDA Adverse Event
Injury
·CYNOSURE, INC.·Product code GEX·January 7, 2014
ELITE MD
FDA Adverse Event
Injury
·CYNOSURE, INC.·Product code GEX·January 7, 2014
DEKA SMARTXIDE2
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 1, 2019
DEKA SMARTXIDE2
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 7, 2019
CYNOSURE CELLULAZE - SLT II
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code OYW·December 18, 2015
ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.
FDA Recall
Terminated
·Ellman International, Inc.·Product code GEI·September 7, 2016
CYNOSURE CELLULAZE - SLT II
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 17, 2016
UNKNOWN
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 7, 2022
Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538
FDA Recall
Terminated
·ConBio, a CynoSure Company·Product code GEX·May 9, 2013
DEKA SMARTXIDE2
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 22, 2021
DEKA SMARTXIDE2
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·December 11, 2019
DEKA SMARTXIDE2
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·January 24, 2024
ICON
FDA Adverse Event
Injury
·CYNOSURE INC·Product code GEX·October 28, 2016
SCULPSURE
FDA Adverse Event
Injury
·CYNOSURE INC·Product code PKT·December 15, 2016
ELITE MPX
FDA Adverse Event
Malfunction
·CYNOSURE INC·Product code GEX·December 15, 2016
ICON
FDA Adverse Event
Injury
·CYNOSURE INC·Product code GEX·October 20, 2016
ICON
FDA Adverse Event
Injury
·CYNOSURE INC·Product code GEX·November 17, 2016
ELITE MD
FDA Adverse Event
Injury
·CYNOSURE INC·Product code GEX·November 2, 2016