8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
GSI 37 AUTO TYMP
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909110952·REVELATION DIAMOND 809-012M - 5 PACK
MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025
FDA 510(k)
FDA Class 2
·Physical Medicine
CARSON MODEL COUDE TIP
FDA Adverse Event
Injury
·CR BARD INC.·Product code KOD·January 2, 2013
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 30, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024