8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756734257·ORTHO SPORTS UCL SUPPLEMENTAL PACK
PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.
FDA 510(k)
FDA Class 2
·Radiology
REALSEAL SE
FDA Adverse Event
Injury
·SYBRONENDO·Product code KIF·June 26, 2014
TECNIS
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·November 11, 2010
CANON X-RAY DIGITAL CAMERA CXDI-22
FDA Adverse Event
Malfunction
·CANON, INC.·Product code MQB·December 31, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021