7 results
·
24ms
·
Sources: EU EUDAMED, US FDA
PROTEC STERILE GAUZE SPONGE
FDA 510(k)
FDA Unclassified
·Unknown
ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM
FDA 510(k)
FDA Class 1
·Immunology
CapsoCam Plus (SV-3) Capsule Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIGASURE ATLAS HANDSWITCHING 37 CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC F(SHANGHAI)·Product code GEI·January 17, 2013
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·January 14, 2011
SELUTE PICOTIP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 28, 2014
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 29, 2022