8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SPR 2 AUTODILUTER
FDA 510(k)
FDA Class 1
·Microbiology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209118915·KIT, IFAK REFILL (zip) - CUSTOM
CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLNT Base and FLNT Temp
FDA 510(k)
FDA Class 2
·Dental
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·April 7, 2014
N/A
FDA Adverse Event
Injury
·ASCENT·Product code NLQ·October 5, 2010
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 30, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024