10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122
FDA 510(k)
FDA Class 2
·Cardiovascular
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
AU5 ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD PANEL PHOENIX NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·October 7, 2021
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 8, 2014
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012
OVATIO
FDA Adverse Event
Injury
·SORIN CRM·Product code MRM·August 10, 2010
AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.
FDA Recall
Terminated
·Abbott Medical Optics Inc (AMO)·Product code LPN·July 23, 2010
AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
FDA Recall
Terminated
·Abbott Medical Optics Inc (AMO)·Product code LPN·July 23, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021