8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MEGA PLUS SUPER LAG SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
PLIF Allograft
FDA UDI
Seaspine Orthopedics Corporation·10889981087791·Modular PLIF Allograft Inserter Handle
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
HCG SCREENING TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TI 12-POINT NUT-11MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·January 25, 2013
RUSCH CRYSTAL TRACHEOSTOMY TUBE - CUFFED 8.0MM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code JOH·November 22, 2010
5MM RATCHETED HANDLE 33CM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·July 11, 2014
EndoVive 3s Low Profile Balloon Kits Part Number: M00549500 (XMD P/N 70-0050-624) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
FDA Enforcement
Class II
·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016