8 results
·
29ms
·
Sources: EU EUDAMED, US FDA
troCarWash System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KARL STORZ ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Elite Biomedical Solutions Dose Request Cord
FDA 510(k)
FDA Class 2
·General Hospital
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 12, 2013
BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JTW·February 21, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018