7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
YUNG HSU OPTICAL WORKS CO
FDA 510(k)
FDA Class 1
·Ophthalmic
FORUM GLAUCOMA WORKPLACE
FDA 510(k)
FDA Class 2
·Radiology
POLYMEDCO OC LIGHT FOBT TEST
FDA 510(k)
FDA Class 2
·Hematology
HT70 PLUS VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·January 31, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 16, 2010
MRH KNEE FEM S RGT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·July 17, 2014
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology