8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220
FDA 510(k)
FDA Class 2
·Cardiovascular
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756732017·CATH LAB ANGIO PACK
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
RADICAL-7 COLOR SCREEN HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·June 13, 2014
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 4, 2013
RADIAL JAW 4 BIOPSY FORCEPS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·November 11, 2010
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024