7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
POWER EXERCISE EQUIPMENT
FDA 510(k)
FDA Class 1
·Physical Medicine
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
FDA 510(k)
FDA Class 1
·General Hospital
JAKOBI SURG. INSTRUMENTS #11 20/25/27/37
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LINOX SMART S 65
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVY·June 16, 2014
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 14, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·June 25, 2015
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