10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
SURGICAL RETRACTOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Walgreens
FDA UDI
WALGREEN CO.·00311917080048·Walgreens Burn Kit
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471179741·Anatomical Molar Bands, Lower Right 1St Molars,...
LYSUS INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NEEDLE, FILTER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 21, 2014
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC·Product code FTL·September 26, 2012
PORTEX SPINAL ANESTHESIA TRAYS
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code CAZ·July 13, 2010
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014