8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRAY, SERVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DEEPVESSEL Plaque
FDA 510(k)
FDA Class 2
·Radiology
BABYAIR
FDA 510(k)
FDA Class 2
·Anesthesiology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 21, 2014
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON INC·Product code FTL·September 26, 2012
SOLETRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·July 15, 2010
Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
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