9 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DENTALIS KEZ ENDODONITC SEALER
FDA 510(k)
FDA Class 2
·Dental
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293753·
Sklar
FDA UDI
SKLAR CORPORATION·10649111122828·POLOKOFF RASP MED S/E 6 1/2 INCHES
MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Atellica IM Ferritin Assay
FDA 510(k)
FDA Class 2
·Immunology
PINNACLE 300 ACET CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·February 21, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·January 27, 2011
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 31, 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