8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
REDDICK RETRACTOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE
FIXATION DEVICES AND BONE PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
PTI ANNULOPLASTY RING(STERILE)
FDA 510(k)
FDA Class 2
·Cardiovascular
CORAIL2 NON COL HO SIZE 11
FDA Adverse Event
Injury
·DEPUY FRANCE·Product code MEH·January 15, 2013
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code NJE·December 6, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 7, 2014
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017