14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGISEAL TOPICAL SKIN ADHESIVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PH BUFFERING PLASTIC APPLICATOR TAMPON
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·March 27, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·August 20, 2008
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018
BD BBLTM CDC ANAEROBE 5% SHEEP BLOOD AGAR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·August 18, 2022
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
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 13, 2026