14 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LMA Fastrach ETT SU
FDA 510(k)
FDA Class 2
·Anesthesiology
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975004048·XX-Fine-/X-Coarse Assorted Benco Dental Absorbe...
SIRION Lateral Lumbar Interbody Fusion
FDA 510(k)
FDA Class 2
·Orthopedic
CUMULASE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS, INC.·Product code LZG·July 23, 2013
VALVE CONTEGRA
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code MWH·February 1, 2019
MELODY TRANSCATHETER PULMONARY VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPV·February 1, 2019
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·February 1, 2019
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·February 1, 2019
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·February 1, 2019
TMC SPEEDMTP
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code GGP·November 19, 2015