7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
FDA 510(k)
FDA Class 2
·Anesthesiology
AMES SERA-PAK CHOLESTEROL REAGENT KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Patient-Specific Airway Stent
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·April 10, 2014
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·October 13, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·December 20, 2012
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015