8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
2.5 FRENCH LITHOTRIPTOR ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756604758·LAPAROSCOPY PACK
CAPS (O.R. NURSE, SURGICAL)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CARDIAN III CR6A
FDA 510(k)
FDA Class 2
·Cardiovascular
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 21, 2014
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·November 5, 2010
SCHNEIDER (VASCULAR LINES)
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MOF·July 11, 2008
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024