7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE
FDA 510(k)
FDA Class 2
·Microbiology
Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFESTENT SOLO VASCULAR STENT SYSTEM
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code NIP·April 16, 2014
45MM ARTICNG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 15, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012
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