9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Partial Flex
FDA 510(k)
FDA Class 2
·Dental
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
P200DTx
FDA 510(k)
FDA Class 2
·Ophthalmic
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
QUANTUM MAVERICK MR BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 19, 2008
STRATA II VALVE, REGULAR
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·July 19, 2013
Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).
FDA Recall
Terminated
·Dow Corning Corp.·September 5, 2003
Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·February 22, 2017
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025