8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
FORMULATION PREPARATION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TRACER SERIES MANUAL WHEELCHAIRS
FDA 510(k)
FDA Class 1
·Physical Medicine
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 11, 2013
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·January 10, 2011
AUTOLUBE-III WITH IRRIGATION
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEY·December 13, 2013
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024