9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
Brigade
FDA UDI
Nuvasive, Inc.·00887517402578·Brigade Implant, 16x38x32mm 12°
BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
IGOXIN SOLID PHASE RIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·EES-ALBUQUERQUE·Product code GDO·March 3, 1997
D-M 1.6MM BEADED CABLE SET VIT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDQ·February 21, 2013
DXTEND STAND PE CUP D38 +3MM
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575·Product code KWS·July 31, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 27, 2011
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