9 results
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19ms
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Sources: EU EUDAMED, US FDA
CW ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS
FDA 510(k)
FDA Class 1
·Ophthalmic
LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VA LOCKSCR Ø2.4 SELF-TAP L18 TAN
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HWC·December 21, 2012
VA LOCKSCR Ø2.4 SELF-TAP L18 TAN
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HWC·December 21, 2012
REVO MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code LWP·February 15, 2013
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·December 22, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2014
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017