8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
EBS 775 TONOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331143113·cottle septum speculum, self-retaining, side ad...
NuVasive Brigade Lateral System
FDA 510(k)
FDA Class 2
·Orthopedic
MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
FDA 510(k)
FDA Class 2
·Radiology
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 30, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2012
BIVONA TTS 4.0 MM UNCUFFED PEDIATRIC TRACHEOSTOMY
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·July 30, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025