8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFIED D-DI-TEST KIT
FDA 510(k)
FDA Class 2
·Hematology
GIALLOY CB/N-H
FDA UDI
SRL Dental GmbH·ESRL58903991·Aufbrennfähige Nichtedelmetall-Dental-Gusslegie...
Beddr 200 System
FDA 510(k)
FDA Class 2
·Cardiovascular
TRIOS SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·July 5, 2015
FORTIFY DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 29, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024