14 results · 21ms · Sources: EU EUDAMED, 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