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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GREINER VACUETTE BLOOD COLLECTION TUBE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PEEK Corpectomy
FDA UDI
Nuvasive, Inc.·00887517623102·PEEK Corp Core, Ø12x20mm
Bioseal Inc.
FDA UDI
BIOSEAL·00630094197128·Silicone Tubing
T3 RIA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COLUMBUS TOTAL KNEE SYSTEM AS
FDA 510(k)
FDA Class 2
·Orthopedic
PELVICOL ACELLULAR COLLAGEN MATRIX 4 X 7 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·February 6, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·January 26, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·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