7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SCANNING DIRECTOR
FDA 510(k)
FDA Class 2
·Physical Medicine
REFERRIL CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
POST MYDRIATIC SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
RESTYLANE INJECTABLE GEL
FDA Adverse Event
Other
·Q-MED AB·Product code LMH·December 22, 2010
INGENIO
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NKE·February 5, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 18, 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