9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FIBEROPTIC LIGHT SOURCE, FOI-1A
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756672023·DOCTOR'S HOSPITAL ANGIOGRAPHYPACK
BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UTERINE CURETTE
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
IDENTITY SR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 16, 2014
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·December 28, 2012
Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp.·March 6, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020