8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Beacon Advanced CO2 Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GUIDED GROWTH PLATE SYSTEM
FDA UDI
ORTHOFIX SRL·18054242518150·EXTENDED PLUS LINE CADDY EMPTY
FEMCHEC PRESSURE MANAGEMET DEVICE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CGA·July 1, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 20, 2013
INTERSTIM
FDA Adverse Event
Malfunction
·MPROC, JUNCOS·Product code EZW·September 29, 2008
SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019